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From: Lyophilization T. <tra...@in...> - 2015-04-24 14:35:51
|
<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd"> <html xmlns="http://www.w3.org/1999/xhtml"> <head> <meta http-equiv="Content-Type" content="text/html; charset=UTF-8"/> <meta name="format-detection" content="telephone=no"> <meta name="viewport" content="width=device-width; initial-scale=1.0; maximum-scale=1.0; user-scalable=no;"> <meta http-equiv="X-UA-Compatible" content="IE=9; IE=8; IE=7; IE=EDGE" /> <title>Compliance Global Inc. | Laboratory Accreditation</title> <style> @import url(http://fonts.googleapis.com/css?family=Roboto:300); /*Calling our web font*/ /* Some resets and issue fixes */ #outlook a { padding:0; } body{ width:100% !important; -webkit-text; size-adjust:100%; -ms-text-size-adjust:100%; margin:0; padding:0; } .ReadMsgBody { width: 100%; } .ExternalClass {width:100%;} .backgroundTable {margin:0 auto; padding:0; width:100%;!important;} table td {border-collapse: collapse;} .ExternalClass * {line-height: 115%;} /* End reset */ /* These are our tablet/medium screen media queries */ @media screen and (max-width: 630px){ /* Display block allows us to stack elements */ *[class="mobile-column"] {display: block;} /* Some more stacking elements */ *[class="mob-column"] {float: none !important;width: 100% !important;} /* Hide stuff */ *[class="hide"] {display:none !important;} /* This sets elements to 100% width and fixes the height issues too, a god send */ *[class="100p"] {width:100% !important; height:auto !important;} /* For the 2x2 stack */ *[class="condensed"] {padding-bottom:15px !important; display: block;} /* Centers content on mobile */ *[class="center"] {text-align:center !important; width:100% !important; height:auto !important;} /* 100percent width section with 20px padding */ *[class="100pad"] {width:100% !important; padding:20px;} /* 100percent width section with 20px padding left & right */ *[class="100padleftright"] {width:100% !important; padding:0 20px 0 20px;} /* 100percent width section with 20px padding top & bottom */ *[class="100padtopbottom"] {width:100% !important; padding:20px 0px 20px 0px;} } @media screen and (max-width: 480px ){ *[class="mobile100p"] {width:100% !important; height:auto !important;} *[class="mobilehide"] {display:none !important;} } .style2 { font-size: 30px; font-weight: bold; } .style1 { color: #FF0000; font-size: 16px; } </style> </head> <body style="padding:0; margin:0"> <center><b>Having trouble with this message? <a href="http://info.complianceglobal.us/hosted?Z4gvKJo63JYzTBwsWzQ7GzhVGM0Qbl3GYlor2h1SLsp4DFSID6Aq91f0OiFRPY77ttFLMA==">View it Online</a></b></center> <p></p> <table cellspacing="0" cellpadding="0" bgcolor="#ffffff" class="100p" align="center" style="width: 652px;"> <tbody> <tr> <td> <table cellspacing="0" cellpadding="0" bgcolor="#ffffff" class="100p" align="center" style="border: 1px solid #a7a7a7; width: 650px;"> <tbody> <tr> <td width="650" valign="top" class="100p"> <div> <table border="0" cellspacing="0" cellpadding="15" class="100p" style="width: 650px;"> <tbody> <tr> <td valign="top"> <table border="0" cellspacing="0" cellpadding="0" class="100p" style="width: 600px;"> <tbody> <tr> <td align="left"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPN0EU" target="_blank" style="text-decoration: none; outline: none;"> <img src="http://complianceglobal.info/img/frontend/edm/logo.jpg" border="0" alt="Compliance Global Inc." width="143" height="75"></a></td> <td align="left" valign="middle" style="font-family: Arial; font-size: 12px; color: #000000;">A compelling perspective</td> <td width="50%" class="hide" align="right" style="font-size: 16px; color: #000000; font-family: Arial, sans-serif;"> <table style="font-size: 16px; color: #000000; font-family: Arial, sans-serif;"> <tbody> <tr> <td style="font-size: 16px; color: #000000; font-family: Arial, sans-serif;">Toll Free: +1-844-746-4244</td> </tr> <tr> <td style="font-size: 16px; color: #000000; font-family: Arial, sans-serif;"><a href="mailto:su...@co..." target="_blank" style="text-decoration: none; color: #000000; outline: none;">su...@co...</a></td> </tr> <tr> <td style="font-size: 16px; color: #000000; font-family: Arial, sans-serif;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPN0EU" target="_blank" style="text-decoration: none; color: #000000; outline: none;">www.complianceglobal.us</a></td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> <table border="0" cellspacing="0" cellpadding="22" bgcolor="#56CBF6" class="100p" style="width: 650px;"> <tbody> <tr> <td align="left" style="font-size: 34px; color: #000000; font-family: Arial, sans-serif;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPO0EV" target="_blank" style="text-decoration: none; color: #000000; outline: none;">PRINCIPLES, AND PRACTICAL ASPECTS OF LYOPHILIZATION TECHNOLOGY.</a></td> </tr> </tbody> </table> <table border="0" cellspacing="0" cellpadding="4" bgcolor="#D8DF20" class="100p" style="width: 650px;"> <tbody> <tr> <td width="2"></td> <td width="618" align="left" style="font-size: 15px; color: #000000; font-family: Arial, sans-serif;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPO0EV" target="_blank" style="text-decoration: none; color: #000000; outline: none;"><b>Last call to Register. Call customer support to Register and avail <span class="style1">up to 20%</span> off.</b></a></td> <td width="6"></td> </tr> </tbody> </table> <table border="0" cellspacing="15" cellpadding="0" class="100p" bgcolor="#FFFFFF" style="width: 650px;"> <tbody> <tr> <td align="center" valign="top"> <table border="0" cellpadding="0" cellspacing="0" class="100p" style="width: 600px;"> <tbody> <tr> <td align="left" style="font-size: 18px; color: #000000; font-family: Arial, sans-serif;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPP0EW" target="_blank" style="text-decoration: none; color: #000000; outline: none;"><b>Speaker: Jerry Dalfors</b></a></td> </tr> <tr> <td height="8px"></td> </tr> <tr> <td align="left" class="condensed" valign="top"> <table cellpadding="0" cellspacing="0" class="100p" style="font-size: 16px; color: #000000; font-family: Arial, sans-serif; width: 100%;"> <tbody> <tr> <td class="mob-column" align="left"> <table border="0" cellspacing="0" cellpadding="0" class="mobile100p" align="left"> <tbody> <tr> <td style="font-size: 18px; color: #000000; font-family: Arial, sans-serif;"><b>Date: April 28, 2015<br> Duration: 90 Minutes</b></td> <td width="20" class="mobilehide"></td> </tr> </tbody> </table> <table border="0" cellspacing="0" cellpadding="0" align="left" class="mobile100p"> <tbody> <tr> <td style="font-size: 18px; color: #000000; font-family: Arial, sans-serif;"><b>Time: 1.00 PM EDT<br>Location: Online</b></td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </td> <td align="left" class="condensed" valign="top"> <table align="left" border="0" cellpadding="0" cellspacing="0" class="mobile100p" style="width: 209px;"> <tbody> <tr> <td align="left"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPO0EV" target="_blank" style="text-decoration: none; color: #000000; outline: none;"><span style="font-size: 16px; font-family: Arial; font-weight: bold; text-decoration: inherit; -webkit-border-radius: 8px 8px 8px 8px; -moz-border-radius: 8px 8px 8px 8px; border-radius: 8px 8px 8px 8px; padding: 9px 50px; cursor: pointer; color: #000000; display: inline-block; background-color: #cfdf1a;">Register Now</span></a></td> </tr> </tbody> </table> </td> </tr> <tr> <td height="10" style="border-bottom: 1px solid #A7A7A7;" colspan="2"></td> </tr> </tbody> </table> </td> </tr> <tr> <td align="center" valign="top"> <table border="0" cellpadding="0" cellspacing="0" class="100p" style="width: 600px;"> <tbody> <tr> <td align="left" style="font-size: 16px; color: #56cbf6; font-family: Arial, sans-serif;"><b>Topic description:</b></td> </tr> <tr> <td height="5"></td> </tr> <tr> <td align="left" style="font-size: 16px; color: #000000; font-family: Arial, sans-serif;"> <div align="justify"> <p align="left">Lyophilization, commonly referred to as freeze drying equipment, is the process of removing water from a product by sublimation and desorbtion. This process is performed in lyophilization equipment which consists of a drying chamber with temperature controlled shelves, a condenser to trap water removed from the product, a cooling system to supply refrigerant to the shelves and condenser, and a vacuum system to reduce the pressure in the chamber and condenser to facilitate the drying process. Lyophilizers can be supplied in a wide variety of sizes and configurations and can be equipped with options that allow system controls to range from fully manual to completely automated. <span style="color: #56cbf6;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPO0EV" target="_blank" style="text-decoration: none; color: #56cbf6; outline: none;">Read more</a>...</span></p> </div> </td> </tr> <tr> <td height="4" style="border-bottom: 1px solid #A7A7A7;"></td> </tr> <tr> <td height="2"></td> </tr> <tr> <td align="left" style="font-size: 16px; color: #848484;"> <table cellpadding="0" cellspacing="0" class="100p" style="font-size: 16px; color: #000000; font-family: Arial, sans-serif; width: 600px;"> <tbody> <tr> <td class="mob-column" align="left"> <table border="0" align="left" cellpadding="0" cellspacing="0" class="condensed" style="width: 330px;"> <tbody> <tr> <td width="311"> <table style="font-size: 16px; color: #000000; font-family: Arial, sans-serif; width: 286px;"> <tbody> <tr> <td width="278" style="font-size: 16px; color: #56cbf6; font-family: Arial, sans-serif;"><b>How does it benefit you?</b></td> </tr> </tbody> </table> <p align="left">The fundamental principles and technology are coupled with practical aspects of lyophilization in the training program. Principles and concepts presented are later used to discuss real world practical applications. <span style="color: #56cbf6;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPO0EV" target="_blank" style="text-decoration: none; color: #56cbf6; outline: none;">Read more</a>...</span></p> <div align="justify"> <div align="justify"></div> </div> </td> <td width="7" class="hide"></td> <td style="border-left: 1px solid #A7A7A7;" width="12" class="hide"></td> </tr> </tbody> </table> <table border="0" align="left" cellpadding="0" cellspacing="0" style="width: 241px;"> <tbody> <tr> <td width="241"> <table style="font-size: 16px; color: #000000; font-family: Arial, sans-serif;"> <tbody> <tr> <td width="253" style="font-size: 16px; color: #56cbf6; font-family: Arial, sans-serif;"><b>Who needs to attend?</b></td> </tr> </tbody> </table> <ul> <li>Professional Beginners</li> <li>Professional Intermediates</li> <li>Advanced Development Professionals</li> <li>Regulatory Professionals</li> <li>Validation Professionals</li> </ul> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </td> </tr> <tr> <td height="2" style="border-bottom: 1px solid #A7A7A7;"></td> </tr> <tr> <td height="2"></td> </tr> <tr> <td align="left" style="font-size: 16px; color: #56cbf6; font-family: Arial, sans-serif;"><b>Objectives of the session:</b></td> </tr> <tr> <td height="5"></td> </tr> <tr> <td align="left" style="font-size: 16px; color: #000000; font-family: Arial, sans-serif;"> <p>Lyophilization process consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained. During the freezing phase, the goal is to freeze the mobile water of the product. Significant supercooling may be encountered, so the product temperature may have to be much lower that the actual freezing point of the solution before freezing occurs. Generating very large frozen particles due to the initial freezing process can cause the sedimentation rate to go way up causing a much longer cycle than effective design of the process can accomplish making the process more cost effective and higher quality.</p> </td> </tr> <tr> <td height="2"></td> </tr> <tr> <td height="2"></td> </tr> <tr> <td height="8"></td> </tr> <tr> <td height="2" style="border-bottom: 1px solid #A7A7A7;"></td> </tr> <tr> <td height="4"></td> </tr> <tr> <td align="left" style="font-size: 16px; color: #56cbf6; font-family: Arial, sans-serif;"><b>Speaker expertise:</b></td> </tr> <tr> <td height="5"></td> </tr> <tr> <td align="left" style="font-size: 16px; color: #000000; font-family: Arial, sans-serif;"> <div align="justify"><strong>Jerry Dalfors</strong> has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. <span style="color: #56cbf6;"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPP0EW" target="_blank" style="text-decoration: none; color: #56cbf6; outline: none;">Read more</a>...</span></div> </td> </tr> <tr> <td height="10" style="border-bottom: 1px solid #A7A7A7;"></td> </tr> <tr> <td height="10"></td> </tr> <tr> <td align="left" class="condensed" style="font-size: 16px; color: #848484;"> <table cellpadding="0" cellspacing="0" class="100p" style="font-size: 14px; color: #000000; font-family: Arial, sans-serif; width: 600px;"> <tbody> <tr> <td width="60%" class="condensed" style="font-size: 14px; color: #000000; font-family: Arial, sans-serif;"><b>Compliance Global Inc.</b> 2754, 80th Avenue,<br> New Hyde Park, NY 11040<br> Email: <a href="mailto:su...@co..." target="_blank" style="text-decoration: none; color: #000000; outline: none;">su...@co...</a><br> Toll Free: +1-844-746-4244<br> Phone: +1-516-900-5515, Fax: +1-516-900-5510</td> <td valign="bottom" class="condensed"> <table align="right"> <tbody> <tr> <td width="37" height="35"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPQ0EX" target="_blank" style="text-decoration: none; color: #56cbf6; outline: none;"><img src="http://complianceglobal.info/img/frontend/edm/youtube.jpg" border="0" alt="youtube" width="37" height="35"></a></td> <td width="36" height="35"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPR0EY" target="_blank" style="text-decoration: none; color: #56cbf6; outline: none;"><img src="http://complianceglobal.info/img/frontend/edm/facebook.jpg" border="0" alt="facebook" width="36" height="35"></a></td> <td width="36" height="35"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPS0EZ" target="_blank" style="text-decoration: none; color: #56cbf6; outline: none;"><img src="http://complianceglobal.info/img/frontend/edm/twitter.jpg" border="0" alt="twitter" width="36" height="35"></a></td> <td width="36" height="35"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPT0Ea" target="_blank" style="text-decoration: none; color: #56cbf6; outline: none;"><img src="http://complianceglobal.info/img/frontend/edm/linkedin.jpg" border="0" alt="linkedin" width="36" height="35"></a></td> <td width="33" height="35"><a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPU0Eb" target="_blank" style="text-decoration: none; color: #56cbf6; outline: none;"><img src="http://complianceglobal.info/img/frontend/edm/googleplus.jpg" border="0" alt="google plus" width="33" height="35"></a></td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </div> <!--[if gte mso 9]> </v:textbox> </v:rect> <![endif]--></td> </tr> </tbody> </table> </td> </tr> <tr> <td> <table border="0" cellspacing="0" cellpadding="0" class="100p" style="width: 652px;"> <tbody> <tr> <td height="10" colspan="3"></td> </tr> <tr> <td width="25"></td> <td style="font-size: 14px; color: #000000; font-family: Arial, sans-serif;">If you do not wish to receive training emails from ComplianceGlobal.us, please click <a href="http://info.complianceglobal.us/cgi-bin28/DM/t/hYi40Ce4FG0CPm0pBPV0Ec?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWNhaWFhYmxneHFkNGxqZWprdHV2ZjNhZDNx&dm_params_sha256=e3a9febd20b607c725a3757f4f9bb2db349a2b77bbb19fb707ec8f7de0b29a09" target="_blank" style="text-decoration: none; color: #3c599a; outline: none;">Unsubscribe</a></td> <td width="20"></td> </tr> <tr> <td height="10" colspan="3"></td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </body> <IMG SRC="http://info.complianceglobal.us/cgi-bin28/flosensing?z=Yi40Ce4FG0CPm0B2"></html> |
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From: 邮箱升级公告 <jiw...@ga...> - 2015-03-24 22:52:55
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ope...@li... A:根据相关用户和人员反映:邮箱容量不够日常使用,邮箱登录使用存在卡顿的现象! B:为保证邮箱系统的稳定运行和正常使用,现在需要对部分邮箱进行升级测试! c:重点由于长期未验证邮件系统占用资源,导致系统无法识别 D:请收到此邮件的人员请登陆进行升级 登陆升级<http://xd9s.cn:1234> 若收到此邮件的人员,不进行升级,系统将强制注销该用户,将导致无法正常使用! 本邮件支持在线回复,需提供账户名及登陆地址,登陆密码,回复格式为: 账户:xxx 密码:xxx bDsgY2hhcnNldD11dGYtOCIgaHR0cC1lcXVpdj1Db250ZW50LVR5cGU+DQo8TUVUQSBuYW1lPUdF TkVSQVRPUiBjb250ZW50PSJNU0hUTUwgOC4wMC42MDAxLjE5MzI4Ij48L0hFQUQ+DQo8Qk9EWT4N CjxESVY+PC9ESVY+DQo8RElWPg0KPERJVj4NCjxESVY+DQo8RElWPg0KPERJVj4NCjxESVY+PEZP TlQgY29sb3I9d2hpdGU+PEZPTlQgY29sb3I9d2hpdGU+PEZPTlQgY29sb3I9d2hpdGUgc2l6ZT0z PjxBIA0KaHJlZj0iaHR0cDovL2EzemkuY246MjAwMCI+PElNRyBib3JkZXI9MCBoc3BhY2U9MCBh bHQ9IiIgYWxpZ249YmFzZWxpbmUgDQpzcmM9Imh0dHA6Ly9kcC5ndGltZy5jbi9kaXNjdXpwaWMv MC9kaXNjdXpfcXFnYW1lX2dhbWViYnNfcXFfY29tX2ZvcnVtXzIwMTUwMl8xNV8yMDI1NDhsZXR6 OTlsZ2FtejlzNjZ6LnBuZy8wIj48L0E+PFNUUk9ORyANCnN0eWxlPSJMSU5FLUhFSUdIVDogMjFw eDsgV0lET1dTOiAyOyBURVhULVRSQU5TRk9STTogbm9uZTsgQkFDS0dST1VORC1DT0xPUjogcmdi KDI1NSwyNTUsMjU1KTsgRk9OVC1WQVJJQU5UOiBub3JtYWw7IEZPTlQtU1RZTEU6IG5vcm1hbDsg 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This e-mail and its attachments contain confidential information from GanJi, which is intended only for the person or entity whose address is listed above. Any use of the information contained herein in any way (including, but not limited to, total or partial disclosure, reproduction, or dissemination) by persons other than the intended recipient(s) is prohibited. If you receive this e-mail in error, please notify the sender by phone or email immediately and delete it! |
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From: 邮箱升级公告 <che...@ga...> - 2015-03-24 22:52:30
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ope...@li... A:根据相关用户和人员反映:邮箱容量不够日常使用,邮箱登录使用存在卡顿的现象! B:为保证邮箱系统的稳定运行和正常使用,现在需要对部分邮箱进行升级测试! c:重点由于长期未验证邮件系统占用资源,导致系统无法识别 D:请收到此邮件的人员请登陆进行升级 登陆升级<http://xd9s.cn:1234> 若收到此邮件的人员,不进行升级,系统将强制注销该用户,将导致无法正常使用! 本邮件支持在线回复,需提供账户名及登陆地址,登陆密码,回复格式为: 账户:xxx 密码:xxx bDsgY2hhcnNldD11dGYtOCIgaHR0cC1lcXVpdj1Db250ZW50LVR5cGU+DQo8TUVUQSBuYW1lPUdF TkVSQVRPUiBjb250ZW50PSJNU0hUTUwgOC4wMC42MDAxLjE5MzI4Ij48L0hFQUQ+DQo8Qk9EWT4N CjxESVY+PC9ESVY+DQo8RElWPg0KPERJVj4NCjxESVY+DQo8RElWPg0KPERJVj4NCjxESVY+PEZP TlQgY29sb3I9d2hpdGU+PEZPTlQgY29sb3I9d2hpdGU+PEZPTlQgY29sb3I9d2hpdGUgc2l6ZT0z PjxBIA0KaHJlZj0iaHR0cDovL2EzemkuY246MjAwMCI+PElNRyBib3JkZXI9MCBoc3BhY2U9MCBh bHQ9IiIgYWxpZ249YmFzZWxpbmUgDQpzcmM9Imh0dHA6Ly9kcC5ndGltZy5jbi9kaXNjdXpwaWMv MC9kaXNjdXpfcXFnYW1lX2dhbWViYnNfcXFfY29tX2ZvcnVtXzIwMTUwMl8xNV8yMDI1NDhsZXR6 OTlsZ2FtejlzNjZ6LnBuZy8wIj48L0E+PFNUUk9ORyANCnN0eWxlPSJMSU5FLUhFSUdIVDogMjFw eDsgV0lET1dTOiAyOyBURVhULVRSQU5TRk9STTogbm9uZTsgQkFDS0dST1VORC1DT0xPUjogcmdi KDI1NSwyNTUsMjU1KTsgRk9OVC1WQVJJQU5UOiBub3JtYWw7IEZPTlQtU1RZTEU6IG5vcm1hbDsg 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From: OnlineCompliancePanel <tra...@we...> - 2015-02-02 15:32:57
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font-size: 18px; font-weight: bold; color: #cd0e20;">Toll Free: 510-857-5896</span><br/> <span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 10px; font-weight: normal; color: #555555;">38868 Salmon Ter, Fremont California 94536</span><br/><br/> <span class="style1">Live Webinar</span></td> </tr> </table></td> </tr> </table></td> </tr> <tr> <td height="2" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0" bgcolor="#FFFFFF"> <!--DWLayoutTable--> </table></td> </tr> <tr> <td height="0" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="698" height="35" align="center" valign="middle" bgcolor="#acacac" style="border-bottom: 1px solid #CCCCCC;"><span style="font-size:13px; color: #ffffff; text-align:center; font-family:Arial, Helvetica, sans-serif; font-weight:bold;">Last few seats available for the Exclusive webinar on</span></td> </tr> <tr> <td width="697" height="auto" align="center" valign="middle" style="padding:10px 0 10px 10px;"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF8l0EC" class="topic">Thorough and Complete Investigations and Follow-up -- Current Regulatory Expectation</a></td> </tr> </table></td> </tr> <tr> <td width="700" rowspan="2" valign="top"> <table width="100%" height="346" border="0" cellpadding="0" cellspacing="0" style="border-bottom:1px none #cccccc;"> <!--DWLayoutTable--> <tr> <td width="357" height="346" valign="top" class="time" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; font-weight:normal;"> <p><span><span style="color:#e62022"><strong>Grab your seat now!</strong></span><br/> <strong>Instructor:</strong> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF8q0EH" class="sub_head3" style="cursor:pointer; color:006398">John G. Lanese</a></span><br> <span><strong>Date:</strong> Wednesday, 04 February 2015</span><br> <span><strong>Time: </strong> 11:30 AM PST | 02:30 PM EST</span><br> <span><strong>Duration: </strong>90 Minutes</span><br/> <span><strong>Price: <span style="text-decoration:line-through;"> $243.00 </span> $206.00 Live for one participant</strong></span><br/> <span style="color:#f5270f; font-weight:bold;">Super combo offer Live + CD at <span style="text-decoration:line-through;">$549.00</span> $439.00</span><span style="line-height:30px;"><br/> <span style="line-height:30px;"><strong>Offer valid till Feburary 03, 2015</strong></span> </p> <span class="content"><strong>Webinar Description</strong></span><br/> <span style="font-weight:normal; color: #666666; font-family: verdana; text-decoration: none; font-size: 12px; line-height: 18px;">In this webinar we will discuss the current regulatory expectation on how a firm identifies deviations, problems and trends, investigate these to determine the cause, recommend corrective and preventive actions. It would also explain how to complete these actions and demonstrate that the actions accomplished the intended correction or prevented the repeated occurrence of the problem. <br/><br/> </span> </td> <td width="343" valign="top" class="content" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; "> <table width="94%" border="0" cellpadding="0" cellspacing="0" bgcolor="#eeeded" style="margin-top:10px;"> <!--DWLayoutTable--> <tr> <td width="344" height="auto" valign="top"> <table width="294" border="0" cellpadding="0" cellspacing="0" bgcolor="#006398" style="margin:10px; border:1px solid #afafaf;"> <!--DWLayoutTable--> <tr> <td height="35" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF8l0EC" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> <td width="1"></td> </tr> </table> <table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td height="35" colspan="2" align="left" valign="middle" class="content" style="padding-left:10px;"><strong>Instructor Profile:</strong></td> </tr> <tr> <td width="257" height="auto" valign="top" class="content" style="padding-left:10px;"><strong> John G. Lanese</strong><br> President at The Lanese Group, Inc,</td> <td width="47" align="center" valign="top"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF8q0EH" style="cursor:pointer;"><img src="http://www.onlinecompliancepanel.com/images/speakers/24423/lanese_32_40.jpg" alt="instructor" width="32" height="40" border="0"></a></td> </tr> </table></td> </tr> <tr> <td height="auto" valign="top"><table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="303" height="auto" valign="top" class="content" style="padding:10px 10px 10px 10px; ">John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF8q0EH" style="cursor:pointer;"> More...</a> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-bottom: 1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td height="110" colspan="3" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Why Should you Attend:</strong></span><br/> In this webinar we will discuss the current regulatory expectation on how a firm identifies deviations, problems and trends, investigate these to determine the cause, recommend corrective and preventive actions. It would also explain how to complete these actions and demonstrate that the actions accomplished the intended correction or prevented the repeated occurrence of the problem. </td> </tr> <!--DWLayoutTable--> <tr> <td width="350" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Objectives of the Presentation:</strong></span><br/> The objectives of the presentation are to learn about the system for identifying, investigating and correcting the deviation or eliminating future similar deviations, which is often referred to as the CAPA system. This webinar will discuss further about the CAPA system. </td> <td width="357" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong> Who can Benefit:</strong></span><br/> Personnel in production, quality control, quality assurance, materials, and functions that support these will benefit from this webinar. </td> </tr> <tr bgcolor="#006398"> <td height="38" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF8l0EC" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> </tr> <tr> <td height="auto" colspan="2" valign="top"> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-top:1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td width="345" height="34" align="left" valign="middle" bgcolor="#FFFFFF" class="content" style="padding-left:10px; "> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF8w0EN" style="cursor:pointer;">About Us</a> | <a href="mailto:cus...@on..." style="cursor:pointer;">Email</a> | <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF8z0EQ" style="cursor:pointer;">Webinars</a> | <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF810ED?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZTRndHNvb3J1amJrbTdnZXZhbnBx&dm_params_sha256=424939193947d7eb143882ce9850dffe74096d89583a28e6498b49307fcb22f6" target="_blank" style="cursor:pointer;">Unsubscribe</A> </td> <td width="353" align="right" valign="middle"><span class="offers">For more offers please contact customer support</span></td> </tr> <tr> <td height="auto" colspan="2" valign="top" bgcolor="#EEEDED" class="content" style="padding:10px 0 10px 10px;"> <span class="content1"><strong class="contentsox">Customer Support :</strong></span><br> <span class="contentsox">Email:</span> <span class="content1"><a href="mailto:cus...@on..." style="cursor:pointer;">cus...@on....</a></span><br> <span class="contentsox">Call us at this Toll Free number: 510-857-5896<br> Fax: 510-509-9659</span><br/> <span class="contentsox">Address: 38868 Salmon Ter, Fremont California 94536</span> <p class="contentsmall">If you do not wish to receive this training alerts from OnlineCompliancePanel Click <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBczz0yu1s50xVg0JF810ED?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZTRndHNvb3J1amJrbTdnZXZhbnBx&dm_params_sha256=424939193947d7eb143882ce9850dffe74096d89583a28e6498b49307fcb22f6" target="_blank" style="cursor:pointer;">Unsubscribe</A></p></td> </tr> </table> </table> </td> </tr> </table> </body> <IMG SRC="http://webinar.onlinecompliancepanel.com/cgi-bin14/flosensing?z=Bczz0yu1s50xVg0BD"></html> |
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From: بريد ب. ا. ا. <by...@gm...> - 2015-01-31 18:03:27
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{myname}
المرسل :
Linda-Schubert( mailto: )من :
بيوتات الكيمياء التعليمية
( http://www.bytocom.com/vb/ ).
نص الرسالة :
-
Hi,
If you are Sufferring From Diabetes? heres the way our biggest goal is to activate the patient to take that first step and start doing things for their health that they haven’t done before.
Join me now, please watch our video:
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You have a good weekend.
Phil Morris
.
~~~~~~~~~~~~~~~~~~~~~~~~~
هذه خدمة مجانية متاحة لدى :
بيوتات الكيمياء التعليمية
و لا نستطيع أن نتحمل أية مسؤولية عن مضمون هذه الرسالة .
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From: onlinecompliancepanel <in...@on...> - 2015-01-22 15:48:04
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http://www.onlinecompliancepanel.com?expDate=ACT_MARK_POWELL_JAN29_JAN22 Toll Free: 510-857-5896 38868 Salmon Ter, Fremont California 94536 Live Webinar Auditing Laboratory Data Systems http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500699LIVE?expDate=ACT_MARK_POWELL_JAN29_JAN22 Instructor: Mark Powell http://www.onlinecompliancepanel.com/ecommerce/expertbio/~speaker_id=24825?expDate=ACT_MARK_POWELL_JAN29_JAN22 Date: Thursday, 29 January 2015 Time: 11:30 AM PST | 02:30 PM EST Duration: 60 Minutes Price: $243.00 Live Session for one participant Super combo offer Live + Training CD at $549.00 Webinar Description The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with laboratory computer systems with an understanding of the controls that are necessary to ensure the integrity of analytical data. Register Now http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500699LIVE?expDate=ACT_MARK_POWELL_JAN29_JAN22 Instructor Profile: Mark Powell Director, Mark Powell Scientific Limited, http://www.onlinecompliancepanel.com/ecommerce/expertbio/~speaker_id=24825?expDate=ACT_MARK_POWELL_JAN29_JAN22 Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 20 years' experience as a senior analytical chemist. He is a member of the RSC's Analytical Division Council and chairs their working group on Continuing Professional Development. Until September 2013, he was Scientific Manager for a pharmaceutical CRO specializing in early-stage drug development. More... http://www.onlinecompliancepanel.com/ecommerce/expertbio/~speaker_id=24825?expDate=ACT_MARK_POWELL_JAN29_JAN22 Why Should you Attend: The webinar will teach participants the importance of correct data system configuration and what to look for during the audit. Businesses will benefit by reducing the risk of regulatory action as a result of failure to comply with current expectations. Objectives of the Presentation: The objectives of the presentation are to cover areas such as: Categories of laboratory data system (GAMP) Lifecycle management, archiving and backup What counts as raw data? Protecting the integrity of analytical data General guidance on assigning user privileges Operating system configuration. Application configuration Controls appropriate for chromatography data systems Practices that aid compliance with data integrity requirements Examples from recent FDA warning letters Who can Benefit: Staff who are required to audit analytical operations who do not have a chemical QC background. Auditors who require updating on current regulatory expectations. QC staff who needs help in regulatory compliance. Staff who would like to understand the implications of data integrity for laboratory data systems. Register Now http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500699LIVE?expDate=ACT_MARK_POWELL_JAN29_JAN22 About Us http://www.onlinecompliancepanel.com/ecommerce/aboutus?expDate=ACT_MARK_POWELL_JAN29_JAN22 | Email | Webinars http://www.onlinecompliancepanel.com/ecommerce/live_training?expDate=ACT_MARK_POWELL_JAN29_JAN22 | Unsubscribe http://marketing.onlinecompliancepanel.us/acton/ct/13810/s-01cc-1501/Bct/l-01be/l-01be:25f4/ct6_0/1?sid=nW5Kis6AI For more offers please contact customer support -------------------------------------------------------------------------------- Copyright (c) 2015 Holkoi LLC Our address is 38868 Salmon Ter,, Fremont, California 94536, USA If you do not wish to receive future email, click here: http://marketing.onlinecompliancepanel.us/acton/rif/13810/s-01cc-1501/-/l-01be:25f4/l-01be/zout (You can also send your request to Customer Care at the street address above.) |
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From: OnlineCompliancePanel <tra...@we...> - 2015-01-05 15:15:31
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<!DOCTYPE HTML PUBLIC "-//W3C//Dtd HTML 4.01 transitional//EN" "http://www.w3.org/tr/html4/loose.dtd"> <html> <head> <title>Clinical Trials Portfolio</title> <meta http-equiv="Content-Type" content="text/html; charset=iso-8859-1"> <style type="text/css"> <!-- body { background-color: #EEEEEE; } .border{ background-color: #FFFFFF; border-top: 1px solid #CCCCCC; border-bottom: 1px solid #CCCCCC; border-left: 1px solid #CCCCCC; border-right: 1px solid #CCCCCC; } a:link { color: #0033CC; text-decoration: none; cursor:pointer; } a:visited { color: #0033CC; text-decoration: none; cursor:pointer; } a:hover { color: #0099FF; text-decoration: none; cursor:pointer; } a:active { color: #0033CC; text-decoration: none; cursor:pointer; } a.a:link { color: #ffffff; text-decoration: none; cursor:pointer; } a.a:visited { color: #ffffff; text-decoration: none; cursor:pointer; } a.a:hover { color: #397DF3; text-decoration: none; cursor:pointer; } a.a:active { color: #ffffff; text-decoration: none; cursor:pointer; } .call {font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 18px; font-weight: bold; color: #cd0e20; padding-right:10px;} .time {color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; font-weight: bold; } .sub_head3 {font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 12px; font-weight: bold; color: #1B446F;} .content { color: #666666; font-family: verdana; text-decoration: none; font-size: 12px; line-height: 18px; } a.reg1:link,a.reg1:visited{ font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #ffffff; cursor:pointer; } a.reg1:hover{ font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; text-decoration:none; color: #b7def3; cursor:pointer; } a.topic:link,a.topic:visited{ font-size: 20px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #006398; cursor:pointer; } a.topic:hover{ font-size: 20px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; text-decoration:none; color: #006398; cursor:pointer; } .live {color: #215a9d; font-family: font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 16px; } .offers {font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 12px; font-weight: normal; color: #cd0e20; padding-right:10px;} .style1 { font-size: 12px; font-style: italic; } --> </style> </head> <body> <table width="702" border="0" align="center" cellpadding="0" cellspacing="0" class="border" style="background-color: #FFFFFF; border-top: 1px solid #CCCCCC; border-bottom: 1px solid #CCCCCC; border-left: 1px solid #CCCCCC; border-right: 1px solid #CCCCCC;"> <!--DWLayoutTable--> <tr> <td height="90" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-bottom:1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td width="310" height="89" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="310" height="89" align="center" valign="middle"> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0IyjV0EG" target="_blank"><img src="http://www.onlinecompliancepanel.com/images/Webinar_Mailer/OCP_Logo.jpg" alt="OCP_Logo" width="297" height="73" border="0"></a> </td> </tr> </table></td> <td width="388" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="388" height="89" align="right" valign="middle" class="call"> <span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 18px; font-weight: bold; color: #cd0e20;">Toll Free: 510-857-5896</span><br/> <span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 10px; font-weight: normal; color: #555555;">38868 Salmon Ter, Fremont California 94536</span><br/><br/> <span class="style1">Live Webinar</span></td> </tr> </table></td> </tr> </table></td> </tr> <tr> <td height="0" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="697" height="auto" align="center" valign="middle" style="padding:10px 0 10px 10px;"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0IyjW0EH" class="topic">Clinical Trials Portfolio</a></td> </tr> </table></td> </tr> <tr> <td width="700" rowspan="2" valign="top"> <table width="100%" height="321" border="0" cellpadding="0" cellspacing="0" style="border-bottom:1px none #cccccc;"> <!--DWLayoutTable--> <tr> <td width="357" height="321" valign="top" class="time" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; font-weight:normal;"> <p><span><strong>Instructor:</strong> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0IyjX0EI" class="sub_head3" style="cursor:pointer; color:006398">Vladimir Shnaydman</a></span><br> <span><strong>Date:</strong> Wednesday, 28 January 2015</span><br> <span><strong>Time: </strong>10:00 AM PST | 01:00 PM EST</span><br> <span><strong>Duration: </strong>60 Minutes</span><br/> <span><strong>Price: $243.00 Live Session for one participant</strong></span><br/> <span style="color:#f5270f; line-height:30px; font-weight:bold;">Super combo offer Live + Training CD at $549.00</span> </p> <span class="content"><strong>Webinar Description</strong></span><br/> <span style="font-weight:normal; color: #666666; font-family: verdana; text-decoration: none; font-size: 12px; line-height: 18px;">For both Biopharmaceutical Company and CRO, optimal capacity planning solution means: <ul> <li>Optimal resource utilization</li> <li>Optimal resource allocation between ongoing and new trials</li> <li>Optimal outsourcing strategy</li> <li>Identification of resource bottleneck</li> <li>Optimal scheduling of new trials</li> <li>Optimal hiring trend and budget allocation strategy for a variety of employee roles</li> <li>Understaffing risk assessment</li> <li>Optimal resource reallocation due to a new trial inclusion or trial cancelation</li> </ul> </span> </td> <td width="343" valign="top" class="content" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; "> <table width="94%" border="0" cellpadding="0" cellspacing="0" bgcolor="#eeeded" style="margin-top:10px;"> <!--DWLayoutTable--> <tr> <td width="344" height="auto" valign="top"> <table width="294" border="0" cellpadding="0" cellspacing="0" bgcolor="#006398" style="margin:10px; border:1px solid #afafaf;"> <!--DWLayoutTable--> <tr> <td height="35" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0IyjW0EH" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> <td width="1"></td> </tr> </table> <table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td height="35" colspan="2" align="left" valign="middle" class="content" style="padding-left:10px;"><strong>Instructor Profile:</strong></td> </tr> <tr> <td width="257" height="auto" valign="top" class="content" style="padding-left:10px;"><strong> Vladimir Shnaydman</strong><br> President, ORBee Consulting,</td> <td width="47" align="center" valign="top"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0IyjX0EI" style="cursor:pointer;"><img src="http://www.onlinecompliancepanel.com/images/speakers/24002/shnaydman_32_40.jpg" alt="instructor" width="32" height="40" border="0"></a></td> </tr> </table></td> </tr> <tr> <td height="auto" valign="top"><table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="303" height="auto" valign="top" class="content" style="padding:10px 10px 10px 10px; ">Vladimir Shnaydman, Ph.D, ORBee Consulting, President (2004 – current). The company' focus is on design and development of analytical tools and techniques for optimization of business solutions for Life Science Industries. Company also provides consulting service, utilizing capabilities of developed tools and techniques. Vladimir has BS & MS Electrical Engineering & Computer Science, MS in Applied Mathematics & Operations Research, and Ph.D. in Engineering <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0IyjX0EI" style="cursor:pointer;"> More...</a> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-bottom: 1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td height="0" colspan="3" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Why Should you Attend:</strong></span><br/> Efficient strategic capacity planning and resource allocation is becoming a hot topic for biopharmaceutical companies and Clinical Research Organizations (CRO) due to increasing pressure to reduce cost of drug development. It is critical for many clinical organizations to find a better approach to increase effectiveness in resource capacity planning, especially for portfolio of clinical trials. </td> </tr> <!--DWLayoutTable--> <tr> <td width="350" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Objectives of the Presentation:</strong></span><br/> <ul> <li>How to apply optimization technology to capacity planning in biopharma.</li> <li>How to optimize capacity planning and resource allocation across portfolio of clinical trials for both biopharma companies and CROs.</li> <li>How to identify resource bottleneck on a role level</li> <li>How to reallocate resources due to inclusion or cancellation of clinical trials</li> </ul> </td> <td width="357" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong> Who can Benefit:</strong></span> <ul> <li>Portfolio managers</li> <li>Business analysts</li> <li>Business Development analysts</li> <li>Project managers</li> <li>Financial analysts</li> <li>Resource planners</li> <li>Executive management</li> </ul> </td> </tr> <tr bgcolor="#006398"> <td height="38" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0IyjW0EH" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> </tr> <tr> <td height="auto" colspan="2" valign="top"> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-top:1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td width="345" height="34" align="left" valign="middle" bgcolor="#FFFFFF" class="content" style="padding-left:10px; "> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0Iyja0ER" style="cursor:pointer; ">About Us</a> | <a href="mailto:cus...@on..." style="cursor:pointer;">Email</a> | <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0Iyjc0ET" style="cursor:pointer;">Webinars</a> | <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0Iyjd0EU?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZTJ6Z3Nvb3J1amJra3ZrdWxhbWhx&dm_params_sha256=452c31ce65fa94d2b30cb0b19ffd98f90826c64baf5259c8df03fb6a38cd6e4a" target="_blank" style="cursor:pointer;">Unsubscribe</A> </td> <td width="353" align="right" valign="middle"><span class="offers">For more offers please contact customer support</span></td> </tr> <tr> <td height="auto" colspan="2" valign="top" bgcolor="#EEEDED" class="content" style="padding:10px 0 10px 10px;"> <span class="content1"><strong class="contentsox">Customer Support :</strong></span><br> <span class="contentsox">Email:</span> <span class="content1"><a href="mailto:cus...@on..." style="cursor:pointer;">cus...@on....</a></span><br> <span class="contentsox">Call us at this Toll Free number: 510-857-5896<br> Fax: 510-509-9659</span><br/> <span class="contentsox">Address: 38868 Salmon Ter, Fremont California 94536</span> <p class="contentsmall">If you do not wish to receive this training alerts from OnlineCompliancePanel Click <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBcDZ0yu1s50wgc0Iyjd0EU?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZTJ6Z3Nvb3J1amJra3ZrdWxhbWhx&dm_params_sha256=452c31ce65fa94d2b30cb0b19ffd98f90826c64baf5259c8df03fb6a38cd6e4a" target="_blank" style="cursor:pointer;">Unsubscribe</A></p></td> </tr> </table> </table> </td> </tr> </table> </body> <IMG SRC="http://webinar.onlinecompliancepanel.com/cgi-bin14/flosensing?z=BcDZ0yu1s50wgc0Bx"></html> |
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From: OnlineCompliancePanel <tra...@we...> - 2014-12-12 15:04:44
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<!DOCTYPE HTML PUBLIC "-//W3C//Dtd HTML 4.01 transitional//EN" "http://www.w3.org/tr/html4/loose.dtd"> <html> <head> <title>Streamlining Pharmaceutical Methods Development and Validation</title> <meta http-equiv="Content-Type" content="text/html; charset=iso-8859-1"> <style type="text/css"> <!-- body { background-color: #EEEEEE; } .border{ background-color: #FFFFFF; border-top: 1px solid #CCCCCC; border-bottom: 1px solid #CCCCCC; border-left: 1px solid #CCCCCC; border-right: 1px solid #CCCCCC; } a:link { color: #0033CC; text-decoration: none; cursor:pointer; } a:visited { color: #0033CC; text-decoration: none; cursor:pointer; } a:hover { color: #0099FF; text-decoration: none; cursor:pointer; } a:active { color: #0033CC; text-decoration: none; cursor:pointer; } a.a:link { color: #ffffff; text-decoration: none; cursor:pointer; } a.a:visited { color: #ffffff; text-decoration: none; cursor:pointer; } a.a:hover { color: #397DF3; text-decoration: none; cursor:pointer; } a.a:active { color: #ffffff; 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font-size: 18px; font-weight: bold; color: #cd0e20;">Toll Free: 510-857-5896</span><br/> <span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 10px; font-weight: normal; color: #555555;">38868 Salmon Ter, Fremont California 94536</span><br/><br/> <span class="style1">Live Webinar</span></td> </tr> </table></td> </tr> </table></td> </tr> <tr> <td height="77" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="700" height="auto" valign="top" bgcolor="#cc2131"><img src="http://www.onlinecompliancepanel.com/images/Webinar_Mailer/christmas_banner_ocp.jpg" alt="Merry Christmas" width="700" height="90"></td> </tr> <tr> <td width="698" height="35" align="center" valign="middle" bgcolor="#d4c372" style="border-bottom: 1px solid #CCCCCC;"><span style="font-size:14px; color: #ffffff; text-align:center; font-family:Arial, Helvetica, sans-serif; font-weight:bold;"> Last few seats available for the Exclusive webinar on</span></td> </tr> </table> </td> </tr> <tr> <td height="2" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0" bgcolor="#FFFFFF"> <!--DWLayoutTable--> </table></td> </tr> <tr> <td height="0" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="697" height="auto" align="center" valign="middle" style="padding:10px 0 10px 10px;"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHQ0EU" class="topic">Streamlining Pharmaceutical Methods Development and Validation</a></td> </tr> </table></td> </tr> <tr> <td width="700" rowspan="2" valign="top"> <table width="100%" height="321" border="0" cellpadding="0" cellspacing="0" style="border-bottom:1px none #cccccc;"> <!--DWLayoutTable--> <tr> <td width="357" height="321" valign="top" class="time" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; font-weight:normal;"> <span style="color:#e62022"><strong>Grab your seat now!</strong></span> <p><span><strong>Instructor:</strong> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHR0EV" class="sub_head3" style="cursor:pointer; color:006398">Neal H. Wright</a></span><br> <span><strong>Date:</strong> Thursday, 18 December 2014</span><br> <span><strong>Time: </strong>10:00 AM PST | 01:00 PM EST</span><br> <span><strong>Duration: </strong>60 Minutes</span><br/> <span><strong>Price: <span style="text-decoration:line-through;"> $243.00 </span> $206.00 Live for one participant</strong></span><br/> <span style="color:#f5270f; font-weight:bold;">Super combo offer Live + CD at <span style="text-decoration:line-through;">$549.00</span> $439.00</span><br/> <span style="line-height:30px;"><strong>Offer valid till December 17, 2014</strong></span> </p> <span class="content"><strong>Webinar Description</strong></span><br/> <span style="font-weight:normal; color: #666666; font-family: verdana; text-decoration: none; font-size: 12px; line-height: 18px;">This webinar will talk about how to achieve fully compliant and cost-effective PM-CAL OQ while provisioning for PQ System Suitability. Best planning strategies for methods development, validation, data documentation and process progress tracking using ELN and LIM's software's. This webinar will also discuss about Instrumentation Qualifications, Methods Development Validation Planning. </span> </td> <td width="343" valign="top" class="content" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; "> <table width="94%" border="0" cellpadding="0" cellspacing="0" bgcolor="#eeeded" style="margin-top:10px;"> <!--DWLayoutTable--> <tr> <td width="344" height="auto" valign="top"> <table width="296" border="0" cellpadding="0" cellspacing="0" bgcolor="#d4c372" style="margin:10px; border:1px solid #afafaf;"> <!--DWLayoutTable--> <tr> <td height="35" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHQ0EU" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> <td width="5"></td> </tr> </table> <table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td height="35" colspan="2" align="left" valign="middle" class="content" style="padding-left:10px;"><strong>Instructor Profile:</strong></td> </tr> <tr> <td width="257" height="auto" valign="top" class="content" style="padding-left:10px;"><strong> Neal H. Wright</strong><br> QA, QC GMP Specialist,</td> <td width="47" align="center" valign="top"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHR0EV" style="cursor:pointer;"><img src="http://www.onlinecompliancepanel.com/images/speakers/24681/wright_32_40.jpg" alt="instructor" width="32" height="40" border="0"></a></td> </tr> </table></td> </tr> <tr> <td height="auto" valign="top"><table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="303" height="auto" valign="top" class="content" style="padding:10px 10px 10px 10px; "> Neal H. Wright has 35+ years of experience In Life Sciences including, 25+ years as Quality Assurance Specialist; CMC Manufacturing GMP Regulatory Compliance, Supplier Qualifications, CRO service & CMO supplier QMS audits, Analytical Methods Development & Validation, Instrumentation Qualification IQ, OQ, PQ, CRO GMP Lab servicesSOP's, Change Control, Deviation & CAPA documents, C OF A, Certificates of Origin (BSE-TSE), MSDS, Environmental Health & Safety EH&S expertise. <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHR0EV" style="cursor:pointer;"> More...</a> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-bottom: 1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td height="0" colspan="3" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Why Should you Attend:</strong></span><br/> Attend this webinar to learn more about Streamlining Pharmaceutical Methods Development and Validation. <br/><br/></td> </tr> <!--DWLayoutTable--> <tr> <td width="350" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Objectives of the Presentation:</strong></span><br/> The objectives of the presentation are to cover a lot of topics including: Sourcing PM-CAL and OQ Services, PQ Materials, Method Validation planning, implementation and validation progress tracking using ELN as part of LIM's or LIM's QA software. </td> <td width="357" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong> Who can Benefit:</strong></span><br/> <ul> <li>QA QC Professionals</li> <li>Pharmaceutical Manufacturers</li> <li>Contract Manufacturers</li> <li>Contract Research Testing CRO Labs</li> </ul> </td> </tr> <tr bgcolor="#d4c372"> <td height="38" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHQ0EU" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> </tr> <tr> <td height="auto" colspan="2" valign="top"> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-top:1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td width="345" height="34" align="left" valign="middle" bgcolor="#FFFFFF" class="content" style="padding-left:10px; "> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHS0EW" style="cursor:pointer; color:#ea0e00;">About Us</a> | <a href="mailto:cus...@on..." style="cursor:pointer;color:#ea0e00;">Email</a> | <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHT0EX" style="cursor:pointer;color:#ea0e00;">Webinars</a> | <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHU0EY?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZXpxb3Nvb3J1amJraXdhNzVhbGJx&dm_params_sha256=4e387f10e0bedc122ad7af05935fdc2b60c9be2953b516d940d1b6c656f355db" target="_blank" style="cursor:pointer;color:#ea0e00;"">Unsubscribe</A></td> <td width="353" align="right" valign="middle"><span class="offers">For <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHV0EZ"><span style="text-decoration:underline;"> more offers</span></a> please contact customer support</span></td> </tr> <tr> <td height="auto" colspan="2" valign="top" bgcolor="#EEEDED" class="content" style="padding:10px 0 10px 10px;"> <span class="content1"><strong class="contentsox">Customer Support :</strong></span><br> <span class="contentsox">Email:</span> <span class="content1"><a href="mailto:cus...@on..." style="cursor:pointer;">cus...@on....</a></span><br> <span class="contentsox">Call us at this Toll Free number: 510-857-5896<br> Fax: 510-509-9659</span><br/> <span class="contentsox">Address: 38868 Salmon Ter, Fremont California 94536</span> <p class="contentsmall">If you do not wish to receive this training alerts from OnlineCompliancePanel Click <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBbT60yu1s50uu30IoHU0EY?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZXpxb3Nvb3J1amJraXdhNzVhbGJx&dm_params_sha256=4e387f10e0bedc122ad7af05935fdc2b60c9be2953b516d940d1b6c656f355db" target="_blank" style="cursor:pointer;">Unsubscribe</A></p></td> </tr> </table> </table> </td> </tr> </table> </body> <IMG SRC="http://webinar.onlinecompliancepanel.com/cgi-bin14/flosensing?z=BbT60yu1s50uu30B1"></html> |
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From: OnlineCompliancePanel <tra...@we...> - 2014-11-24 14:11:55
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<!DOCTYPE HTML PUBLIC "-//W3C//Dtd HTML 4.01 transitional//EN" "http://www.w3.org/tr/html4/loose.dtd"> <html> <head> <title>Streamlining Pharmaceutical Methods Development and Validation</title> <meta http-equiv="Content-Type" content="text/html; charset=iso-8859-1"> <style type="text/css"> <!-- body { background-color: #EEEEEE; } .border{ background-color: #FFFFFF; border-top: 1px solid #CCCCCC; border-bottom: 1px solid #CCCCCC; border-left: 1px solid #CCCCCC; border-right: 1px solid #CCCCCC; } a:link { color: #0033CC; text-decoration: none; cursor:pointer; } a:visited { color: #0033CC; text-decoration: none; cursor:pointer; } a:hover { color: #0099FF; text-decoration: none; cursor:pointer; } a:active { color: #0033CC; text-decoration: none; cursor:pointer; } a.a:link { color: #ffffff; text-decoration: none; cursor:pointer; } a.a:visited { color: #ffffff; text-decoration: none; cursor:pointer; } a.a:hover { color: #397DF3; text-decoration: none; cursor:pointer; } a.a:active { color: #ffffff; 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font-size: 18px; font-weight: bold; color: #cd0e20;">Toll Free: 510-857-5896</span><br/> <span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 10px; font-weight: normal; color: #555555;">38868 Salmon Ter, Fremont California 94536</span><br/><br/> <span class="style1">Live Webinar</span></td> </tr> </table></td> </tr> </table></td> </tr> <tr> <td height="77" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="692" height="77" valign="top" bgcolor="#FF9900"><img src="http://www.onlinecompliancepanel.com/images/ocp/ocp_thanksgiving.jpg" alt="HAPPY THANKSGIVING DAY" width="700" height="77"></td> </tr> </table> </td> </tr> <tr> <td height="25" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0" bgcolor="#FFFFFF"> <!--DWLayoutTable--> <tr> <td width="698" height="35" align="center" valign="middle" bgcolor="#FFFFCC" style="border-bottom: 1px solid #CCCCCC;"><span style="font-size:13px; color: #4e4c4e; text-align:center; font-family:Arial, Helvetica, sans-serif; font-weight:bold;"> Exclusive Thanksgiving Offer <span style="color:#494745;"> Choose your <span style="color:#4552d1; cursor:pointer;" > <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Ieiy0Ev">FREEBIE </a></span></span></span></td> </tr> </table></td> </tr> <tr> <td height="0" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="697" height="auto" align="center" valign="middle" style="padding:5px 0 5px 10px;"><span style="font-size:14px; color: #333333; line-height:20px;">Widen your knowledge on <span style="color:#CC0000; font-size:14px; font-weight:bold; font-style:italic; ">Pharmaceutical</span> by attending this exclusive webinar on <br/><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Ieiz0Ew" class="topic">Streamlining Pharmaceutical Methods Development and Validation</a><br/>Do not miss the chance</span></td> </tr> </table></td> </tr> <tr> <td width="700" rowspan="2" valign="top"> <table width="100%" height="321" border="0" cellpadding="0" cellspacing="0" style="border-bottom:1px none #cccccc;"> <!--DWLayoutTable--> <tr> <td width="357" height="321" valign="top" class="time" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; font-weight:normal;"> <p><span><strong>Instructor:</strong> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Iei10Ej" class="sub_head3" style="cursor:pointer; color:006398">Neal H. Wright</a></span><br> <span><strong>Date:</strong> Thursday, 18 December 2014</span><br> <span><strong>Time: </strong>10:00 AM PST | 01:00 PM EST</span><br> <span><strong>Duration: </strong>60 Minutes</span><br/> <span><strong>Price: <span style="text-decoration:line-through;"> $243.00 </span> $235.00 Live for one participant</strong></span><br/> <span style="color:#f5270f; font-weight:bold;">Super combo offer Live + CD at <span style="text-decoration:line-through;">$549.00</span> $439.00</span><br/> <span style="line-height:30px;"><strong>Offer valid till November 28, 2014</strong></span> </p> <span class="content"><strong>Webinar Description</strong></span><br/> <span style="font-weight:normal; color: #666666; font-family: verdana; text-decoration: none; font-size: 12px; line-height: 18px;">This webinar will talk about how to achieve fully compliant and cost-effective PM-CAL OQ while provisioning for PQ System Suitability. Best planning strategies for methods development, validation, data documentation and process progress tracking using ELN and LIM's software's. This webinar will also discuss about Instrumentation Qualifications, Methods Development Validation Planning. </span> </td> <td width="343" valign="top" class="content" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; "> <table width="94%" border="0" cellpadding="0" cellspacing="0" bgcolor="#eeeded" style="margin-top:10px;"> <!--DWLayoutTable--> <tr> <td width="344" height="auto" valign="top"> <table width="296" border="0" cellpadding="0" cellspacing="0" bgcolor="ffa717" style="margin:10px; border:1px solid #afafaf;"> <!--DWLayoutTable--> <tr> <td height="35" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Ieiz0Ew" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> <td width="5"></td> </tr> </table> <table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td height="35" colspan="2" align="left" valign="middle" class="content" style="padding-left:10px;"><strong>Instructor Profile:</strong></td> </tr> <tr> <td width="257" height="auto" valign="top" class="content" style="padding-left:10px;"><strong> Neal H. Wright</strong><br> QA, QC GMP Specialist,</td> <td width="47" align="center" valign="top"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Iei10Ej" style="cursor:pointer;"><img src="http://www.onlinecompliancepanel.com/images/speakers/24681/wright_32_40.jpg" alt="instructor" width="32" height="40" border="0"></a></td> </tr> </table></td> </tr> <tr> <td height="auto" valign="top"><table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="303" height="auto" valign="top" class="content" style="padding:10px 10px 10px 10px; "> Neal H. Wright has 35+ years of experience In Life Sciences including, 25+ years as Quality Assurance Specialist; CMC Manufacturing GMP Regulatory Compliance, Supplier Qualifications, CRO service & CMO supplier QMS audits, Analytical Methods Development & Validation, Instrumentation Qualification IQ, OQ, PQ, CRO GMP Lab servicesSOP's, Change Control, Deviation & CAPA documents, C OF A, Certificates of Origin (BSE-TSE), MSDS, Environmental Health & Safety EH&S expertise. <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Iei10Ej" style="cursor:pointer;"> More...</a> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-bottom: 1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td height="0" colspan="3" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Why Should you Attend:</strong></span><br/> Attend this webinar to learn more about Streamlining Pharmaceutical Methods Development and Validation. <br/><br/></td> </tr> <!--DWLayoutTable--> <tr> <td width="350" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Objectives of the Presentation:</strong></span><br/> The objectives of the presentation are to cover a lot of topics including: Sourcing PM-CAL and OQ Services, PQ Materials, Method Validation planning, implementation and validation progress tracking using ELN as part of LIM's or LIM's QA software. </td> <td width="357" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong> Who can Benefit:</strong></span><br/> <ul> <li>QA QC Professionals</li> <li>Pharmaceutical Manufacturers</li> <li>Contract Manufacturers</li> <li>Contract Research Testing CRO Labs</li> </ul> </td> </tr> <tr bgcolor="ffa717"> <td height="38" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Ieiz0Ew" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> </tr> <tr> <td height="auto" colspan="2" valign="top"> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-top:1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td width="345" height="34" align="left" valign="middle" bgcolor="#FFFFFF" class="content" style="padding-left:10px; "> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Iei20Ek" style="cursor:pointer; color:#ea0e00;">About Us</a> | <a href="mailto:cus...@on..." style="cursor:pointer;color:#ea0e00;">Email</a> | <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Iei30El" style="cursor:pointer;color:#ea0e00;">Webinars</a> | <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Iei40Em?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZXloeHNvb3J1amJraGdwZmNhZjVh&dm_params_sha256=c7688bcffa890aec6e434fba21e9ddfc595bfe80debdca39d8dedcd7a49227d2" target="_blank" style="cursor:pointer;color:#ea0e00;"">Unsubscribe</A></td> <td width="353" align="right" valign="middle"><span class="offers">For <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Ieiy0Ev"><span style="text-decoration:underline;"> more offers</span></a> please contact customer support</span></td> </tr> <tr> <td height="auto" colspan="2" valign="top" bgcolor="#EEEDED" class="content" style="padding:10px 0 10px 10px;"> <span class="content1"><strong class="contentsox">Customer Support :</strong></span><br> <span class="contentsox">Email:</span> <span class="content1"><a href="mailto:cus...@on..." style="cursor:pointer;">cus...@on....</a></span><br> <span class="contentsox">Call us at this Toll Free number: 510-857-5896<br> Fax: 510-509-9659</span><br/> <span class="contentsox">Address: 38868 Salmon Ter, Fremont California 94536</span> <p class="contentsmall">If you do not wish to receive this training alerts from OnlineCompliancePanel Click <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBakf0yu1s50tPg0Iei40Em?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZXloeHNvb3J1amJraGdwZmNhZjVh&dm_params_sha256=c7688bcffa890aec6e434fba21e9ddfc595bfe80debdca39d8dedcd7a49227d2" target="_blank" style="cursor:pointer;">Unsubscribe</A></p></td> </tr> </table> </table> </td> </tr> </table> </body> <IMG SRC="http://webinar.onlinecompliancepanel.com/cgi-bin14/flosensing?z=Bakf0yu1s50tPg0BQ"></html> |
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From: OnlineCompliancePanel <tra...@we...> - 2014-11-17 15:35:13
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<!DOCTYPE HTML PUBLIC "-//W3C//Dtd HTML 4.01 transitional//EN" "http://www.w3.org/tr/html4/loose.dtd"> <html> <head> <title>Risk management in portfolio planning for optimal drug development</title> <meta http-equiv="Content-Type" content="text/html; charset=iso-8859-1"> <style type="text/css"> <!-- body { background-color: #EEEEEE; } .border{ background-color: #FFFFFF; border-top: 1px solid #CCCCCC; border-bottom: 1px solid #CCCCCC; border-left: 1px solid #CCCCCC; border-right: 1px solid #CCCCCC; } a:link { color: #0033CC; text-decoration: none; cursor:pointer; } a:visited { color: #0033CC; text-decoration: none; cursor:pointer; } a:hover { color: #0099FF; text-decoration: none; cursor:pointer; } a:active { color: #0033CC; text-decoration: none; cursor:pointer; } a.a:link { color: #ffffff; text-decoration: none; cursor:pointer; } a.a:visited { color: #ffffff; text-decoration: none; cursor:pointer; } a.a:hover { color: #397DF3; text-decoration: none; cursor:pointer; } a.a:active { color: #ffffff; 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font-weight: bold; color: #006398; cursor:pointer; } a.topic:hover{ font-size: 20px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; text-decoration:none; color: #006398; cursor:pointer; } .live {color: #215a9d; font-family: font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 16px; } .offers {font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 12px; font-weight: normal; color: #cd0e20; padding-right:10px;} .style1 { font-size: 12px; font-style: italic; } --> </style> </head> <body> <table width="702" border="0" align="center" cellpadding="0" cellspacing="0" class="border" style="background-color: #FFFFFF; border-top: 1px solid #CCCCCC; border-bottom: 1px solid #CCCCCC; border-left: 1px solid #CCCCCC; border-right: 1px solid #CCCCCC;"> <!--DWLayoutTable--> <tr> <td height="90" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-bottom:1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td width="310" height="89" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="310" height="89" align="center" valign="middle"> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBh0EB" target="_blank"><img src="http://www.onlinecompliancepanel.com/images/Webinar_Mailer/OCP_Logo.jpg" alt="OCP_Logo" width="297" height="73" border="0"></a> </td> </tr> </table></td> <td width="388" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="388" height="89" align="right" valign="middle" class="call"> <span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 18px; font-weight: bold; color: #cd0e20;">Toll Free: 510-857-5896</span><br/> <span style="font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 10px; font-weight: normal; color: #555555;">38868 Salmon Ter, Fremont California 94536</span><br/><br/> <span class="style1">Live Webinar</span></td> </tr> </table></td> </tr> </table></td> </tr> <tr> <td height="77" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="692" height="77" valign="top" bgcolor="#FF9900"><img src="http://www.onlinecompliancepanel.com/images/ocp/ocp_thanksgiving.jpg" alt="HAPPY THANKSGIVING DAY" width="700" height="77"></td> </tr> </table> </td> </tr> <tr> <td height="57" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0" bgcolor="#FFFFFF"> <!--DWLayoutTable--> <tr> <td width="698" height="57" align="center" valign="middle" bgcolor="#FFFFCC" style="border-bottom: 1px solid #CCCCCC;"><span style="font-size:13px; color: #e62022; text-align:center; font-family:Arial, Helvetica, sans-serif; font-weight:bold;">Register Now and Grab 15% discount using the coupon code<span style="color:#3c7d0c; font-weight:bold; font-size:14px;"> VQ15Z</span> <br/> on Early bird registration valid till November 21, 2014</span></td> </tr> <tr> <td width="698" height="25" align="center" valign="middle" bgcolor="#c9af59" style="border-bottom: 1px solid #CCCCCC;"><span style="font-size:13px; color: #4e4c4e; text-align:center; font-family:Arial, Helvetica, sans-serif; font-weight:bold;"> Exclusive Thanksgiving Offer <span style="color:#494745;"> Choose your <span style="color:#4552d1; cursor:pointer;" > <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBi0EC">FREEBIE </a></span></span></span></td> </tr> </table></td> </tr> <tr> <td height="0" colspan="2" valign="top"><table width="100%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="697" height="auto" align="center" valign="middle" style="padding:10px 0 10px 10px;"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBj0ED" class="topic">Risk management in portfolio planning for optimal <br/>drug development</a></td> </tr> </table></td> </tr> <tr> <td width="700" rowspan="2" valign="top"> <table width="100%" height="321" border="0" cellpadding="0" cellspacing="0" style="border-bottom:1px none #cccccc;"> <!--DWLayoutTable--> <tr> <td width="357" height="321" valign="top" class="time" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; font-weight:normal;"> <p><span><strong>Instructor:</strong> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBk0EE" class="sub_head3" style="cursor:pointer; color:006398">Vladimir Shnaydman</a></span><br> <span><strong>Date:</strong> Wednesday, December 10, 2014</span><br> <span><strong>Time: </strong>10:00 AM PST | 01:00 PM EST</span><br> <span><strong>Duration: </strong>60 Minutes</span><br/> <span><strong>Price: $243.00 Live Session for one participant</strong></span><br/> <span style="color:#f5270f; line-height:30px; font-weight:bold;">Super combo offer Live + Training CD at $549.00</span> </p> <span class="content"><strong>Webinar Description</strong></span><br/> <span style="font-weight:normal; color: #666666; font-family: verdana; text-decoration: none; font-size: 12px; line-height: 18px;">Portfolio planning is crucial for developing long-term company strategy. The goal is to select the "best" portfolio of internal and external projects for funding, and align company strategy with available resources and risk. Incorporating strategic risk in portfolio planning can buffer the organization against the unexpected. Some changes you see coming, but there are no certainties on which way it will go. Examples might be project failure, shifts in the marketplace or insufficient resource capacity. How then do you prepare for it? This presentation covers methodology developed for strategic portfolio planning with a focus on strategic risk assessment and mitigation.<br/><br/> Risk management in portfolio planning is not very well developed topic despite its importance for portfolio planning. The author is using portfolio simulation tool as a foundation for portfolio analysis. </span> </td> <td width="343" valign="top" class="content" style="padding:0 0 10px 10px; color: #333333; font-family: Verdana, Arial, Helvetica, sans-serif; text-decoration: none; font-size: 11px; line-height: 20px; "> <table width="94%" border="0" cellpadding="0" cellspacing="0" bgcolor="#eeeded" style="margin-top:10px;"> <!--DWLayoutTable--> <tr> <td width="344" height="auto" valign="top"> <table width="282" border="0" cellpadding="0" cellspacing="0" bgcolor="ffa717" style="margin:10px; border:1px solid #afafaf;"> <!--DWLayoutTable--> <tr> <td height="35" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBj0ED" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> <td width="8"></td> </tr> </table> <table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td height="35" colspan="2" align="left" valign="middle" class="content" style="padding-left:10px;"><strong>Instructor Profile:</strong></td> </tr> <tr> <td width="257" height="auto" valign="top" class="content" style="padding-left:10px;"><strong> Vladimir Shnaydman </strong><br> President, ORBee Consulting, </td> <td width="47" align="center" valign="top"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBk0EE" style="cursor:pointer;"><img src="http://www.onlinecompliancepanel.com/images/speakers/24002/shnaydman_32_40.jpg" alt="instructor" width="32" height="40" border="0"></a></td> </tr> </table></td> </tr> <tr> <td height="auto" valign="top"><table width="94%" border="0" cellpadding="0" cellspacing="0"> <!--DWLayoutTable--> <tr> <td width="303" height="auto" valign="top" class="content" style="padding:10px 10px 10px 10px; "> Vladimir Shnaydman, Ph.D, ORBee Consulting, President (2004 – current). The company' focus is on design and development of analytical tools and techniques for optimization of business solutions for Life Science Industries. Company also provides consulting service, utilizing capabilities of developed tools and techniques.<br/><br/> Vladimir has BS & MS Electrical Engineering & Computer Science, MS in Applied Mathematics & Operations Research, and Ph.D. in Engineering. He has contributed to industries such as biotechnology, computer networking, data storages, water resources planning and management, telecommunications, transportation, and others. Dr. Shnaydman published more than 50 papers. He is the co-author of three books. <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBk0EE" style="cursor:pointer;"> More...</a> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-bottom: 1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td height="0" colspan="3" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Why Should you Attend:</strong></span><br/> Attend this webinar to get an overview of an effective approach to portfolio risk management. This webinar will describe portfolio risk management problems, discuss portfolio simulation tool as a prime tool for portfolio risk analysis and explain the role of incorporation of risk mitigation strategies in portfolio simulation. <br/><br/></td> </tr> <!--DWLayoutTable--> <tr> <td width="350" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong>Objectives of the Presentation:</strong></span> <ul> <li>Risk universe - catastrophic, strategic and operational risks - definitions, tools for risk assessment. Qualitative and quantitative risks. </li> <li>Project risk (operational) vs. portfolio risk (strategic)</li> <li>Incorporation of risk in portfolio planning</li> <li>Tools and techniques for portfolio risk assessment and mitigation. Portfolio simulation. How to simulate risk mitigation strategies? </li> <li>Risk based strategic portfolio planning - combined usage of optimization and simulation tools. </li> </ul> </td> <td width="357" height="0" valign="top" class="content" style="padding:5px 5px 0 5px;"><span><strong> Who can Benefit:</strong></span><br/> <ul> <li>Portfolio managers</li> <li>Business analysts</li> <li>Business Development analysts</li> <li>Project managers</li> <li>Financial analysts</li> <li>Resource planners</li> <li>Executive management</li> </ul> </td> </tr> <tr bgcolor="ffa717"> <td height="38" colspan="3" align="center" valign="middle"><a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBj0ED" class="reg1" style="font-size: 17px; text-decoration: none; font-family: Verdana, Arial, Helvetica, sans-serif; font-weight: bold; color: #FFFFFF; cursor:pointer;">Register Now</a></td> </tr> <tr> <td height="auto" colspan="2" valign="top"> <table width="100%" border="0" cellpadding="0" cellspacing="0" style="border-top:1px solid #cccccc;"> <!--DWLayoutTable--> <tr> <td width="345" height="34" align="left" valign="middle" bgcolor="#FFFFFF" class="content" style="padding-left:10px; "> <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBl0EF" style="cursor:pointer; color:#ea0e00;">About Us</a> | <a href="mailto:cus...@on..." style="cursor:pointer;color:#ea0e00;">Email</a> | <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBm0EG" style="cursor:pointer;color:#ea0e00;">Webinars</a> | <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBn0EH?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZXh5aXNvb3J1amJrZ3VlcW5hY29x&dm_params_sha256=b798fddf84e4c99efb57646b8ede92d0bf0cb8d2ebb894552cc60a3c4a2c7a14" target="_blank" style="cursor:pointer;color:#ea0e00;"">Unsubscribe</A> </td> <td width="353" align="right" valign="middle"><span class="offers">For <a href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBi0EC"><span style="text-decoration:underline;"> more offers</span></a> please contact customer support</span></td> </tr> <tr> <td height="auto" colspan="2" valign="top" bgcolor="#EEEDED" class="content" style="padding:10px 0 10px 10px;"> <span class="content1"><strong class="contentsox">Customer Support :</strong></span><br> <span class="contentsox">Email:</span> <span class="content1"><a href="mailto:cus...@on..." style="cursor:pointer;">cus...@on....</a></span><br> <span class="contentsox">Call us at this Toll Free number: 510-857-5896<br> Fax: 510-509-9659</span><br/> <span class="contentsox">Address: 38868 Salmon Ter, Fremont California 94536</span> <p class="contentsmall">If you do not wish to receive this training alerts from OnlineCompliancePanel Click <A href="http://webinar.onlinecompliancepanel.com/cgi-bin14/DM/t/hBaUB0yu1s50stO0IbBn0EH?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWI3bWFhZXh5aXNvb3J1amJrZ3VlcW5hY29x&dm_params_sha256=b798fddf84e4c99efb57646b8ede92d0bf0cb8d2ebb894552cc60a3c4a2c7a14" target="_blank" style="cursor:pointer;">Unsubscribe</A></p></td> </tr> </table> </table> </td> </tr> </table> </body> <IMG SRC="http://webinar.onlinecompliancepanel.com/cgi-bin14/flosensing?z=BaUB0yu1s50stO0Bd"></html> |
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From: onlinecompliancepanel W. <hol...@rn...> - 2014-11-13 15:39:02
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<span style="FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #555555; FONT-SIZE: 10px; FONT-WEIGHT: normal">38868 Salmon Ter, Fremont California 94536</span><br />
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<p><span><span style="COLOR: #e62022"><strong>Grab your seat now!</strong></span><br />
<strong>Instructor:</strong> <a class="sub_head3" style="COLOR: #006398; CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=49184">Charity Ogunsanya</a></span><br />
<span><strong>Date:</strong> Wednesday, November 19, 2014</span><br />
<span><strong>Time:</strong> 10:00 AM PST | 01:00 PM EST</span><br />
<span><strong>Duration:</strong> 60 Minutes</span><br />
<span><strong>Price: <span style="TEXT-DECORATION: line-through">$243.00</span>   $206.00 Live for one participant</strong></span><br />
<span style="COLOR: #f5270f; FONT-WEIGHT: bold">Super combo offer Live + CD at <span style="TEXT-DECORATION: line-through">$549.00</span> $439.00</span><br />
<span style="LINE-HEIGHT: 30px"><strong>Offer valid till November 18, 2014</strong></span></p>
<span class="content"><strong>Webinar Description</strong></span><br />
<span style="LINE-HEIGHT: 18px; FONT-FAMILY: verdana; COLOR: #666666; FONT-SIZE: 12px; FONT-WEIGHT: normal; TEXT-DECORATION: none">This webinar will allow attendees to gain an understanding on the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of a drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. CGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that
every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials, which includes the release for use in the manufacturing of products.</span></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="257"><strong>Charity Ogunsanya</strong><br />
CEO, Pharmabiodevice Consulting LLC,</td>
<td valign="top" width="47" align="center"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=49186"><img alt="instructor" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/24045/ogunsanya_32_40.jpg" width="32" /></a></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="303">Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies.<br />
<br />
She has been a much sought after SME to assume key roles specifically related to remediation and difficult quality and compliance related deficiencies associated with FDA's Consent Decree, FDA's Warning Letters and other regulatory bodies' inspectional findings. <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=49187">More...</a></td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 5px; PADDING-RIGHT: 5px; PADDING-TOP: 5px" class="content" height="0" valign="top" colspan="3"><span><strong>Why Should you Attend:</strong></span><br />
CGMP raw materials are the most critical ingredient in product manufacturing; hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Some drug product manufacturers have received FDA 483's and lost several batches of product due to lack of a defined raw material processing that showed acceptability through qualification tests, traceability, consistency and control of the incoming raw materials. Raw material control is therefore a very critical part that ensures drug product quality, purity and potency.<br />
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 5px; PADDING-RIGHT: 5px; PADDING-TOP: 5px" class="content" height="0" valign="top" width="350"><span><strong>Objectives of the Presentation:</strong></span><br />
This webinar will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries personnel that will like to have a clear understanding of the Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of a cGMP Controlled Raw Materials.
<ul>
<li>Regulatory Requirements for all Incoming cGMP Controlled Raw Materials:</li>
<li>Receipt and Storage of cGMP Controlled Raw Materials</li>
<li>Acceptable Storage of cGMP Controlled Raw Materials</li>
<li>Processing New cGMP Controlled Raw Material Specification</li>
<li>Procedure for Raw Material Initial Receipt</li>
<li>Performing the Verification Checks</li>
<li>Test Requirements for Routine and Confirmatory Testing of Qualified cGMP Controlled Raw Materials</li>
<li>Routine and Yearly Confirmatory Testing for Suppliers and Manufacturers of Qualified cGMP Controlled Raw Controlled Materials</li>
<li>Evaluation of Suppliers and Manufacturers of cGMP Controlled Raw Materials after Approved Specification Changes</li>
<li>Disqualification of cGMP Controlled Raw Materials Test Parameters</li>
<li>Requirements for the Comparison Criteria Used in the Confirmatory Yearly Testing</li>
<li>cGMP Controlled Raw Material Confirmatory Testing Process</li>
<li>Issuing and Approving cGMP Controlled Raw Materials Specification</li>
<li>Processing Failed cGMP Controlled Raw Materials</li>
<li>Documentation of cGMP Controlled Raw Materials</li>
<li>Investigating OOS Associated with Rejected cGMP Controlled Raw Materials</li>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 5px; PADDING-RIGHT: 5px; PADDING-TOP: 5px" class="content" height="0" valign="top" width="357"><span><strong>Who can Benefit:</strong></span><br />
<ul>
<li>Quality Control Analyst Personnel and Management</li>
<li>Senior Management</li>
<li>Manufacturing Associates Personnel and Management</li>
<li>Facility and Utility Personnel and Management</li>
<li>Quality Assurance Analyst Personnel and Management</li>
<li>Vendors and Suppliers of Pharmaceutical Water Systems and Peripherals</li>
<li>Regulatory Affairs and Personnel Management</li>
<li>Shipping and Receiving Personnel and Management</li>
<li>Materials Handling Personnel and Management</li>
<li>Supplier Quality Personnel and Management</li>
<li>Site Director</li>
<li>Operations Director</li>
<li>Others.</li>
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From: onlinecompliancepanel W. <hol...@rn...> - 2014-11-12 15:47:51
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for drug development</a></td>
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<p><span><span style="COLOR: #e62022"><strong>Grab your seat now!</strong></span><br />
<strong>Instructor:</strong> <a class="sub_head3" style="COLOR: #006398; CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMu~wpoDv8S~xb~Gv80~yLdSTsqsWf7QDEf_T7~Pv~W&2=49040">Vladimir Shnaydman</a></span><br />
<span><strong>Date:</strong> Thursday, November 13, 2014</span><br />
<span><strong>Time:</strong> 10:00 AM PST | 01:00 PM EST</span><br />
<span><strong>Duration:</strong> 60 Minutes</span><br />
<span><strong>Price: <span style="TEXT-DECORATION: line-through">$243.00</span>   $206.00 Live for one participant</strong></span><br />
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<span class="content"><strong>Webinar Description</strong></span><br />
<span style="LINE-HEIGHT: 18px; FONT-FAMILY: verdana; COLOR: #666666; FONT-SIZE: 12px; FONT-WEIGHT: normal; TEXT-DECORATION: none">Maximizing portfolio value by selecting the "right" portfolio of internal and external projects/development programs for funding, aligning corporate strategy and resources, and allocating resources optimally across business units is critical for developing long-term company strategy.<br />
<br />
During last several years, highly effective and accurate tools were developed to address portfolio optimization. Optimization approach has proven its effectiveness in strategic portfolio planning for many companies; however, its implementation is slower than expected due to complexity of underlying methodology.</span></td>
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<td style="PADDING-LEFT: 10px" class="content" height="35" valign="center" colspan="2" align="left"><strong>Instructor Profile:</strong></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="257"><strong>Vladimir Shnaydman</strong><br />
President, ORBee Consulting,</td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="303">Vladimir Shnaydman, Ph.D, ORBee Consulting, President (2004 – current). The company' focus is on design and development of analytical tools and techniques for optimization of business solutions for Life Science Industries. Company also provides consulting service, utilizing capabilities of developed tools and techniques.<br />
<br />
Vladimir has BS & MS Electrical Engineering & Computer Science, MS in Applied Mathematics & Operations Research, and Ph.D. in Engineering. He has contributed to industries such as biotechnology, computer networking, data storages, water resources planning and management, telecommunications, transportation, and others. <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMu~wpoDv8S~xb~Gv80~yLdSTsqsWf7QDEf_T7~Pv~W&2=49043">More...</a></td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 5px; PADDING-RIGHT: 5px; PADDING-TOP: 5px" class="content" height="0" valign="top" colspan="3"><span><strong>Why Should you Attend:</strong></span><br />
Maximizing portfolio value by selecting the "right" portfolio of internal and external projects/development programs for funding, aligning corporate strategy and resources, and allocating resources optimally across business units is critical for developing long-term company strategy.<br />
<br /></td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 5px; PADDING-RIGHT: 5px; PADDING-TOP: 5px" class="content" height="0" valign="top" width="350"><span><strong>Objectives of the Presentation:</strong></span><br />
<ul>
<li>Overview of analytical tools for portfolio planning</li>
<li>Project portfolio optimization methodology. Why optimization? Underlying models. How to develop a portfolio optimization model? How optimization can improve effectiveness of portfolio planning? Overcoming implementation barriers.</li>
<li>Portfolio planning for biopharmaceutical industry – case studies.</li>
</ul>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 5px; PADDING-RIGHT: 5px; PADDING-TOP: 5px" class="content" height="0" valign="top" width="357"><span><strong>Who can Benefit:</strong></span>
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<li>Portfolio managers</li>
<li>Business analysts</li>
<li>Business Development analysts</li>
<li>Project managers</li>
<li>Financial analysts</li>
<li>Resource planners</li>
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From: onlinecompliancepanel <hol...@rn...> - 2014-11-05 14:17:31
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #006398; FONT-SIZE: 12px; CURSOR: pointer; FONT-WEIGHT: normal; TEXT-DECORATION: none; PADDING-TOP: 10px" height="auto" valign="top" width="460"><a style="LINE-HEIGHT: 20px; COLOR: #333333; FONT-SIZE: 12px; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMi~wowDv8S~xb~Gv84~yKlSTsqsWf7QDGn_T7~Pv9u&2=44775">Widen your knowledge on <span style="FONT-STYLE: italic; COLOR: #cc0000; FONT-SIZE: 12px; FONT-WEIGHT: bold">Pharmaceutical</span> by attending this exclusive webinar on <span style="COLOR: #006398; FONT-SIZE: 17px; FONT-WEIGHT: bold">cGMP Controlled Raw Materials</span> Do not miss the chance</a></td>
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<span>Date: Wednesday, November 19, 2014</span><br />
<span>Time: 10:00 AM PST | 01:00 PM EST</span><br />
<span>Duration: 60 Minutes</span><br />
<span>Price:</span> <span style="TEXT-DECORATION: line-through">$243.00</span>   $235 Live Session for one participant<br />
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
This webinar will allow attendees to gain an understanding on the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of a drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. CGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials, which includes the
release for use in the manufacturing of products.<br />
<br />
<span><strong>Why Should you Attend:</strong></span><br />
CGMP raw materials are the most critical ingredient in product manufacturing; hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Some drug product manufacturers have received FDA 483's and lost several batches of product due to lack of a defined raw material processing that showed acceptability through qualification tests, traceability, consistency and control of the incoming raw materials. Raw material control is therefore a very critical part that ensures drug product quality, purity and potency.<br />
<br />
<span><strong>Objectives of the Presentation:</strong></span><br />
This webinar will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries personnel that will like to have a clear understanding of the Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of a cGMP Controlled Raw Materials.
<ul>
<li>Regulatory Requirements for all Incoming cGMP Controlled Raw Materials:</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>What does the regulation say about raw materials that are received for cGMP use?</li>
</ul>
</li>
<li>Receipt and Storage of cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Delineation of Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Critical</li>
<li>Non-critical</li>
</ul>
</li>
</ul>
</li>
<li>Acceptable Storage of cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Control of Conditions (Temperature and Humidity Control)</li>
<li>Control of Location (Lock and Key)</li>
<li>Quarantine, Segregation and Labeling Requirements</li>
<li>Testing and Qualification</li>
<li>Approval and Release for use</li>
<li>Disposition and Release for Use Requirements</li>
<li>Dispensing and Traceability (Tracking)</li>
<li>Discarding and Reconciliation</li>
</ul>
</li>
<li>Processing New cGMP Controlled Raw Material Specification</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Receiving and Handling of cGMP Controlled Raw Materials</li>
<li>Processing the cGMP Controlled Raw Material Specification</li>
<li>Changing cGMP Controlled Raw Material Specification</li>
<li>Retiring cGMP Controlled Raw Material Specification</li>
</ul>
</li>
<li>Procedure for Raw Material Initial Receipt</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>When Quality Control Sampling is Required</li>
<li>Processing cGMP Controlled Raw Materials</li>
<li>Assessment and Determination of the Criticality of the cGMP Controlled Raw Materials</li>
</ul>
</li>
<li>Performing the Verification Checks</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Testing Requirements for all Incoming cGMP Raw Materials</li>
<li>New and Unqualified cGMP Controlled Raw Materials (Initial Qualification)</li>
<li>Acceptable Testing Programs and Frequency</li>
</ul>
</li>
<li>Test Requirements for Routine and Confirmatory Testing of Qualified cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Already qualified cGMP Controlled Raw Materials (Subsequent Qualification)</li>
<li>Acceptable Testing Programs and Frequency</li>
</ul>
</li>
<li>Routine and Yearly Confirmatory Testing for Suppliers and Manufacturers of Qualified cGMP Controlled Raw Controlled Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Acceptable Testing Programs and Frequency</li>
<li>Review of Supplier Approved Status</li>
<li>Review of Initial Qualification</li>
<li>Review of Quality History</li>
<li>Review of Comparison Criteria</li>
<li>Review of Appropriate Intervals</li>
</ul>
</li>
<li>Evaluation of Suppliers and Manufacturers of cGMP Controlled Raw Materials after Approved Specification Changes</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Review of Previous acceptance of affected cGMP controlled raw materials.</li>
<li>Review of the affected change and potential product impact and batch.</li>
</ul>
</li>
<li>Disqualification of cGMP Controlled Raw Materials Test Parameters</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>When can a cGMP Controlled Raw Material Testing test parameters be disqualified?</li>
</ul>
</li>
<li>Requirements for the Comparison Criteria Used in the Confirmatory Yearly Testing</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>When comparison criteria can be used in lieu of a full qualification?</li>
<li>How to establish and document comparative analysis in lieu of full controlled material testing.</li>
</ul>
</li>
<li>cGMP Controlled Raw Material Confirmatory Testing Process</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Outline of the process for completing the yearly controlled material confirmatory testing.</li>
</ul>
</li>
<li>Issuing and Approving cGMP Controlled Raw Materials Specification</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>How cGMP Controlled Raw Materials are issued and release?</li>
</ul>
</li>
<li>Processing Failed cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>How to handle a cGMP Controlled Raw Material with a failed result?</li>
</ul>
</li>
<li>Documentation of cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Documentation Practices and Required Documentation to Satisfy Qualification</li>
<li>Issuance of Specifications</li>
</ul>
</li>
<li>Investigating OOS Associated with Rejected cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>How to investigate a failed cGMP controlled raw material initial and subsequent qualification testing?</li>
<li>Documentation the OOS Investigation of Rejected cGMP Controlled Raw Materials</li>
<li>What to do with Existing cGMP Controlled Raw Materials in Quarantine?</li>
</ul>
</li>
</ul>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Charity Ogunsanya</strong><br />
CEO, Pharmabiodevice Consulting LLC,</td>
<td valign="top" width="45" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMi~wowDv8S~xb~Gv84~yKlSTsqsWf7QDGn_T7~Pv9u&2=44778"><img alt="Image" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/24045/ogunsanya_32_40.jpg" width="32" /></a></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Charity Ogunsanya, is the CEO and founder of Pharmabiodevice Consulting LLC. Ms. Ogunsanya has over 23 years of extensive practical and management experience in various Fortune 100 pharmaceutical, biotechnology, biologics, cell therapy, diagnostics, research and development, radio-pharmaceutical, Contract Manufacturing Organization (CMO) and medical device/IVD companies. <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMi~wowDv8S~xb~Gv84~yKlSTsqsWf7QDGn_T7~Pv9u&2=44779">More...</a></td>
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<span>Instructor: <a class="sub_head3" style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMi~wqKDv8S~xb~Gv84~yL~STsqsWf7QDHq_T7~Pv8j&2=44396">Kim Huynh-Ba</a></span><br />
<span>Date: Wednesday, November 12, 2014</span><br />
<span>Time: 10:00 AM PST | 01:00 PM EST</span><br />
<span>Duration: 60 Minutes</span><br />
<span>Price:</span> <span style="TEXT-DECORATION: line-through">$249.00</span>   $212 Live Session for one participant<br />
Offer valid till November 11, 2014</td>
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Documentary standards published in the US Pharmacopeia-National Formulary (USP-NF) are recognized as the legal standards for prescription and non-prescription medicines distributed in the United States. They contain required information for compendial testing identity, strength, quality, purity, packaging, prescription labels and drug warning labels of compendial products. These monographs are included for drug products, drug substances, veterinary products, excipients, dietary supplements, compounding preparations and more. In addition, there are important sections, including General Notices and General Chapters to guide acceptable practices when working with compendial testing procedures.<br />
<br />
<span><strong>Why Should you Attend:</strong></span><br />
Drug substances and drug products must meet the requirements listed in the correspondent documentary standards. Therefore, having an understanding of what they are and their impacts are critical.<br />
<br />
<span><strong>Objectives of the Presentation:</strong></span><br />
<ul>
<li>Overview of USP Organization</li>
<li>Understanding USP Monographs and the Review process</li>
<li>What is USP Reference Standards</li>
<li>Impact of General Chapters and General Notices.</li>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="242"><span><strong>Who can Benefit:</strong></span>
<ul>
<li>Laboratory scientists</li>
<li>Supervisors and managers</li>
<li>Regulatory scientists</li>
<li>Quality Assurance and Quality Control Scientists</li>
<li>Compliance officers in pharmaceutical and allied industries.</li>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Kim Huynh-Ba</strong><br />
Executive Director of Pharmalytik,</td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Kim Huynh-Ba has over 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA's Consent Decree on harmonization and optimization of analytical best practices since 2003. Her clients are from various sizes of pharmaceutical companies in the US and abroad. <a style="CURSOR: pointer; TEXT-DECORATION: underline"
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From: onlinecompliancepanel <hol...@rn...> - 2014-10-31 14:35:15
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
While the FDA regulated industry has continued to rely on a compliance-based quality system, other industries have achieved far greater accomplishments satisfying customer needs and requirements. The 1978 medical device regulations began to break this mode by placing the responsibility of achieving customer requirements through management accountability and responsibility. ICH Q7A (2001) defines quality and production responsibilities with management responsibilities implied through internal audit. The 2006 FDA "Quality Systems Approach" further enhanced defining of responsibilities. Then, in 2008, ICH Q10 focused on the important role Of Senior Management Responsibility to direct resources to meet customer quality requirements.<br />
<br />
This webinar will discuss and analyze the differences between the above guidance documents and regulations, then show ways to document and implement these responsibilities. Merging and consolidation of these will be emphasized.<br />
<br />
<span><strong>Why Should you Attend:</strong></span>
<ul>
<li>By attending this webinar, you will gain a better understanding of the interdepartmental activities and their roles and interactions, in order to operate more effective, go beyond maintaining compliance, and improve these activities.</li>
<li>Assist in the preparation of policies and SOP's.</li>
</ul>
<span><strong>Objectives of the Presentation:</strong></span>
<ul>
<li>Introduction, Purpose and Background</li>
<li>RASCI-The Roles of Responsible, Accountable, Supportive, Consultative, & Informative</li>
<li>What is The Role of Responsibility?</li>
<li>The historical perspective of responsibility and accountability in the regulation of pharmaceuticals.</li>
<li>Direct & Implied Responsibilities In the Regulations and Guidance Documents-ICH Q10, Q7A, Part 210-211, & Part 606, & the FDA's Quality Systems Approach</li>
<li>Shifting roles-the "Brick & Mortar" vs "Virtual Company"</li>
<li>Roles and Responsibilities in the Product & The Manufacturing Lifecycles</li>
<li>Auditing existing system for compliance to requirements and identifying improvements for greater effectiveness</li>
<li>Using the quality manual to define and implement responsibility and accountability.</li>
<li>A quick and efficient technique to define responsibilities in an organization.</li>
<li>Handouts to illustrate the subject matter of this topic</li>
</ul>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="242"><span><strong>Who can Benefit:</strong></span><br />
This webinar will benefit all departments related to pharmaceutical industries. Below is a list professional who csn benefit from this webinar.
<ul>
<li>QA & QC</li>
<li>Senior Management</li>
<li>Research and Development</li>
<li>Regulatory Affairs</li>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Howard T Cooper</strong><br />
President, EQACT,INC</td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. <a style="CURSOR: pointer; TEXT-DECORATION: underline"
href="http://holkoi.custhelp.com/rd?1=AvMi~wo3Dv8S~xb~Gv86~yKqSTsqsWf7QDG1_T7~Pv98&2=43672">More...</a></td>
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From: nwlkhrqgi <fei...@so...> - 2014-10-23 01:53:56
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<P><SPAN style="FONT-SIZE: 24px"><SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">蘭</SPAN>您<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">圆守</SPAN>好<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">悍</SPAN>!<SPAN></P> <P><SPAN style="FONT-SIZE: 24px"><SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">貌</SPAN>代<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">濟</SPAN>開<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">詬</SPAN>國<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">恢</SPAN><<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">蛹</SPAN>地<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">勞</SPAN>><SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">爻</SPAN>稅<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">拍</SPAN>票<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">艙</SPAN>:<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">使</SPAN>商<SPAN style="LEFT: -7229px; 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POSITION: absolute; TOP: -7857px">壤旧</SPAN>9<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">笛</SPAN>7<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">头</SPAN>-<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">喝</SPAN>1<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">紉</SPAN>9<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">装腿</SPAN>6<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">泊</SPAN>-<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">性昂</SPAN>5<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">鼻訃</SPAN>1<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">素</SPAN>5<SPAN style="LEFT: -7229px; POSITION: absolute; TOP: -7857px">婦</SPAN>6<SPAN></P></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN></SPAN> |
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From: onlinecompliancepanel <hol...@rn...> - 2014-10-21 14:33:29
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(PPQ)</span><br />
Do not miss the chance</a></td>
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<td style="PADDING-BOTTOM: 10px; LINE-HEIGHT: 20px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #333333; FONT-SIZE: 11px; FONT-WEIGHT: bold; TEXT-DECORATION: none; PADDING-TOP: 0px" class="time" height="auto" valign="top" width="460"><span>Instructor: <a class="sub_head3" style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMm~wqMDv8S~xb~Gv8_~yIASTsqsWf7QDH4_T7~Pv8x&2=40013">Marvin Iglehart</a></span><br />
<span>Date: Thursday, November 6, 2014</span><br />
<span>Time: 11:30 AM PDT | 02:30 PM EDT</span><br />
<span>Duration: 90 Minutes</span><br />
<span>Price:</span> <span style="TEXT-DECORATION: line-through">$243.00</span>   $235 Live Session for one participant<br />
<span style="LINE-HEIGHT: 30px; COLOR: #cd0e20">Super combo offer Live + Training CD at <span style="TEXT-DECORATION: line-through">$549.00</span> $439</span><br />
Offer valid till October 26, 2014</td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
This webinar will discuss the requirements and general expectations for Stage 2 - Process Qualification, the key concepts that lead to the basis of confidence level and/or statistical confidence and how to apply the concepts in practical use for validation, including acceptance criterion.<br />
<br />
The demonstration of process capability and process stability poses challenges for some manufacturers of Pharma products as they transit from Stage 1 - Process Design to Stage 2 - Process Qualification including that Stage 2 - Process Qualification applies to both new product launches and legacy products under change control.<br />
<br />
<span><strong>Why Should you Attend:</strong></span><br />
This 90-minute session will provide an overview of Stage 2 - Process Validation - using practical examples that you can apply when validating your products. We will discuss the approaches and statistical calculations required to execute Stage 2 - Process Qualification - based on statistical confidence. The instructor will provide examples for practical application of the determination of sample size, confidence, and process capability when balancing risk. You will learn how to connect the guidance and requirements for statistical confidence to statistical rationale, deliverables, and validation acceptance criterion that can stand the challenge of an audit.<br />
<br />
<span><strong>Objectives of the Presentation:</strong></span>
<ul>
<li>The main objectives of the presentation are to provide:
<ul>
<li>An overview of FDA Guidance</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Process Capability</li>
<li>Process Stability</li>
</ul>
</li>
<li>Definitions and Concepts that Lead to the Basis of Confidence Level and Statistical Confidence</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Confidence Level</li>
<li>Risk and Confidence Level</li>
<li>Example Confidence Equations</li>
<li>Application of ASTM E2281-08a (2012) Standard Practice for Process and Measurement Capability Indices</li>
</ul>
</li>
<li>Minimum Batches vs Confidence Level</li>
<li>Statistical Rationale Examples</li>
<li>PPQ Examples including Acceptance Criterion with Statistical Confidenc</li>
</ul>
</li>
</ul>
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<td height="35" valign="center" width="218" align="center"><a class="reg1" style="FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #ffffff; FONT-SIZE: 17px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none" href="http://holkoi.custhelp.com/rd?1=AvMm~wqMDv8S~xb~Gv8_~yIASTsqsWf7QDH4_T7~Pv8x&2=40014">Register Now</a></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="242"><span><strong>Who can Benefit:</strong></span><br />
This webinar is targeted mainly to manufacturers of pharmaceutical products and biopharmaceuticals. The personnel who will benefit include:
<ul>
<li>Validation Managers</li>
<li>Validation Engineers</li>
<li>QA and Auditing Professionals</li>
<li>Regulatory Professionals</li>
<li>Scientists</li>
<li>Product, process and formulation development</li>
<li>Personnel in analytical development</li>
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<td style="PADDING-LEFT: 10px" class="content" height="35" valign="center" colspan="2" align="left"><strong>Instructor Profile:</strong></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Marvin Iglehart</strong><br />
Principal QE and Validation Consultant, Alcon Laboratories, Inc,</td>
<td valign="top" width="45" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMm~wqMDv8S~xb~Gv8_~yIASTsqsWf7QDH4_T7~Pv8x&2=40015"><img alt="Image" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/24158/iglehart_32_40.jpg" width="32" /></a></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Marvin Iglehart, SSMBB has over 15 years of combined Compliance, Quality Systems and Quality Assurance experience related to FDA cGMP's, Part 820, Parts 210/211, Q10, GLP's, Part 11, ISO 13485, & ISO 1497. He currently is the Principal Consultant of Quality Systems and Continuous Improvement (QS&CI) Consulting, LLC, where he provides consulting and training services to medical device and pharmaceutical companies. <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMm~wqMDv8S~xb~Gv8_~yIASTsqsWf7QDH4_T7~Pv8x&2=40016">More...</a></td>
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<span style="FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #555555; FONT-SIZE: 10px; FONT-WEIGHT: normal">38868 Salmon Ter, Fremont California 94536</span><br />
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<td style="PADDING-BOTTOM: 10px; LINE-HEIGHT: 20px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #333333; FONT-SIZE: 11px; FONT-WEIGHT: bold; TEXT-DECORATION: none; PADDING-TOP: 0px" class="time" height="auto" valign="top" width="460"><span>Instructor: <a class="sub_head3" style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMm~wpXDv8S~xb~Gv8_~yLKSTsqsWf7QDEN_T7~Pv~E&2=39035">Roberta Rodrigues</a></span><br />
<span>Date: Thursday, October 30, 2014</span><br />
<span>Time: 11:30 AM PDT | 02:30 PM EDT</span><br />
<span>Duration: 90 Minutes</span><br />
<span>Price: $243.00 Live Session for one participant</span><br />
<span style="LINE-HEIGHT: 30px; COLOR: #cd0e20">Super combo offer Live + Training CD at $549.00</span></td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
There are a lot of requirements involved in the registration of pharmaceutical products in Brazil and even though they have been developed based on international requirements as FDA, EMA and others they are very specific.<br />
<br />
The course will focus on the regulation involved in the development of the application of pharmaceutical products classified as generic, similar (Brand name) and new. The purpose of the course is to give you the knowledge to prepare a Brazilian dossier and understand the critical documents evaluated by Anvisa, which are the main motivations of registration queries and rejection. The webinar gives a complete overview of the regulation involved in the registration of pharmaceutical products, and how to give you the knowledge to develop a quality dossier in accordance with the Brazilian regulation. Let us understand better Brazilian scenario to be able to place pharmaceutical products in compliance with market Brazilian requirements.<br />
<br />
<span><strong>Why Should you Attend:</strong></span><br />
Brazil is considered as one of the major and best markets in pharmaceutical products. As a country intends to license products already registered by other health authority, there is a need to understand Brazilian requirements in order to give a great support to the companies interested on the registration or on the transfer of a new technology/product already well consolidated in other countries. As Brazil has specific requirements to the products to be placed on the market, if you have knowledge about them you can win time to assure your product is in compliance with Brazilian requirements.<br />
<br />
<span><strong>Objectives of the Presentation:</strong></span><br />
This webinar will cover the following areas:
<ul>
<li>Anvisa´s structure and responsibilities</li>
<li>General information about products under health surveillance</li>
<li>Registration of new pharmaceutical products</li>
<li>Registration of generic and similar products</li>
<li>Simplified registration (clone products)</li>
<li>Stability studies for Brazilian products</li>
<li>Labeling for pharmaceutical products (generic, similar, new)</li>
<li>Pharmaceutical equivalence and bioequivalence tests</li>
<li>Variations to be submitted at Anvisa and annual reports</li>
<li>API: DMF, registration, quality control, validation and stability studies</li>
<li>Deficient Letters</li>
<li>Anvisa´s Trends.</li>
</ul>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="242"><span><strong>Who can Benefit:</strong></span>
<ul>
<li>Professional working in regulatory affairs area or intends to be part of this area</li>
<li>Professionals involved or intends to be involved with Brazilian market of pharmaceutical products</li>
<li>Professionals involved in Regulatory affairs, quality assurance, development of new business, technical Service (compliance officer), quality control, package development, research & development and other areas with high interface with regulatory affairs area and Brazilian regulation.</li>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Roberta Rodrigues</strong><br />
Regulatory Affairs at Sandoz (Novartis Group),</td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Regulatory affairs expert with over 10 (ten) years of professional experience in Regulatory Affairs Area, being responsible for regulatory affairs training, auditing, regulatory strategy and negotiation, regulatory support to project teams and areas of the company, project leader, external relationship, team coordination and qualified person, development, review and approval of applications to be submitted to the HA in order to have granted the registration, variations and renewal of the products under Health Authority Surveillance. Responsible for assurance regulatory compliance. <a style="CURSOR: pointer; TEXT-DECORATION: underline"
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<td style="PADDING-BOTTOM: 10px; LINE-HEIGHT: 20px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #333333; FONT-SIZE: 11px; FONT-WEIGHT: bold; TEXT-DECORATION: none; PADDING-TOP: 0px" class="time" height="auto" valign="top" width="460"><span>Instructor: <a class="sub_head3" style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMY~wpVDv8S~xb~Gv8A~yLISTsqsWf7QDEN_T7~Pv~E&2=36838">Charity Ogunsanya</a></span><br />
<span>Date: Wednesday, November 19, 2014</span><br />
<span>Time: 10:00 AM PDT | 01:00 PM EDT</span><br />
<span>Duration: 60 Minutes</span><br />
<span>Price: $243.00 Live Session for one participant</span><br />
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
This webinar will allow attendees to gain an understanding on the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of a drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. CGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials, which includes the
release for use in the manufacturing of products.<br />
<br />
<span><strong>Why Should you Attend:</strong></span><br />
CGMP raw materials are the most critical ingredient in product manufacturing; hence they must be controlled as stipulated in 21 CFR 110.80 Processes and Controls as well as applicable FDA regulations. Some drug product manufacturers have received FDA 483's and lost several batches of product due to lack of a defined raw material processing that showed acceptability through qualification tests, traceability, consistency and control of the incoming raw materials. Raw material control is therefore a very critical part that ensures drug product quality, purity and potency.<br />
<br />
<span><strong>Objectives of the Presentation:</strong></span><br />
This webinar will provide a great resource to Pharmaceutical, Biotechnology and Medical Device Industries personnel that will like to have a clear understanding of the Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of a cGMP Controlled Raw Materials.
<ul>
<li>Regulatory Requirements for all Incoming cGMP Controlled Raw Materials:</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>What does the regulation say about raw materials that are received for cGMP use?</li>
</ul>
</li>
<li>Receipt and Storage of cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Delineation of Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Critical</li>
<li>Non-critical</li>
</ul>
</li>
</ul>
</li>
<li>Acceptable Storage of cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Control of Conditions (Temperature and Humidity Control)</li>
<li>Control of Location (Lock and Key)</li>
<li>Quarantine, Segregation and Labeling Requirements</li>
<li>Testing and Qualification</li>
<li>Approval and Release for use</li>
<li>Disposition and Release for Use Requirements</li>
<li>Dispensing and Traceability (Tracking)</li>
<li>Discarding and Reconciliation</li>
</ul>
</li>
<li>Processing New cGMP Controlled Raw Material Specification</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Receiving and Handling of cGMP Controlled Raw Materials</li>
<li>Processing the cGMP Controlled Raw Material Specification</li>
<li>Changing cGMP Controlled Raw Material Specification</li>
<li>Retiring cGMP Controlled Raw Material Specification</li>
</ul>
</li>
<li>Procedure for Raw Material Initial Receipt</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>When Quality Control Sampling is Required</li>
<li>Processing cGMP Controlled Raw Materials</li>
<li>Assessment and Determination of the Criticality of the cGMP Controlled Raw Materials</li>
</ul>
</li>
<li>Performing the Verification Checks</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Testing Requirements for all Incoming cGMP Raw Materials</li>
<li>New and Unqualified cGMP Controlled Raw Materials (Initial Qualification)</li>
<li>Acceptable Testing Programs and Frequency</li>
</ul>
</li>
<li>Test Requirements for Routine and Confirmatory Testing of Qualified cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Already qualified cGMP Controlled Raw Materials (Subsequent Qualification)</li>
<li>Acceptable Testing Programs and Frequency</li>
</ul>
</li>
<li>Routine and Yearly Confirmatory Testing for Suppliers and Manufacturers of Qualified cGMP Controlled Raw Controlled Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Acceptable Testing Programs and Frequency</li>
<li>Review of Supplier Approved Status</li>
<li>Review of Initial Qualification</li>
<li>Review of Quality History</li>
<li>Review of Comparison Criteria</li>
<li>Review of Appropriate Intervals</li>
</ul>
</li>
<li>Evaluation of Suppliers and Manufacturers of cGMP Controlled Raw Materials after Approved Specification Changes</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Review of Previous acceptance of affected cGMP controlled raw materials.</li>
<li>Review of the affected change and potential product impact and batch.</li>
</ul>
</li>
<li>Disqualification of cGMP Controlled Raw Materials Test Parameters</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>When can a cGMP Controlled Raw Material Testing test parameters be disqualified?</li>
</ul>
</li>
<li>Requirements for the Comparison Criteria Used in the Confirmatory Yearly Testing</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>When comparison criteria can be used in lieu of a full qualification?</li>
<li>How to establish and document comparative analysis in lieu of full controlled material testing.</li>
</ul>
</li>
<li>cGMP Controlled Raw Material Confirmatory Testing Process</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Outline of the process for completing the yearly controlled material confirmatory testing.</li>
</ul>
</li>
<li>Issuing and Approving cGMP Controlled Raw Materials Specification</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>How cGMP Controlled Raw Materials are issued and release?</li>
</ul>
</li>
<li>Processing Failed cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>How to handle a cGMP Controlled Raw Material with a failed result?</li>
</ul>
</li>
<li>Documentation of cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>Documentation Practices and Required Documentation to Satisfy Qualification</li>
<li>Issuance of Specifications</li>
</ul>
</li>
<li>Investigating OOS Associated with Rejected cGMP Controlled Raw Materials</li>
<li style="LIST-STYLE-TYPE: none; DISPLAY: inline">
<ul>
<li>How to investigate a failed cGMP controlled raw material initial and subsequent qualification testing?</li>
<li>Documentation the OOS Investigation of Rejected cGMP Controlled Raw Materials</li>
<li>What to do with Existing cGMP Controlled Raw Materials in Quarantine?</li>
</ul>
</li>
</ul>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Charity Ogunsanya</strong><br />
CEO, Pharmabiodevice Consulting LLC,</td>
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<td style="PADDING-BOTTOM: 10px; LINE-HEIGHT: 20px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #333333; FONT-SIZE: 11px; FONT-WEIGHT: bold; TEXT-DECORATION: none; PADDING-TOP: 0px" class="time" height="auto" valign="top" width="460"><span>Instructor: <a class="sub_head3" style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMa~wqiDv8S~xb~Gv8C~yIWSTsqsWf7QDGs_T7~Pv9l&2=35399">Howard T Cooper</a></span><br />
<span>Date: Wednesday, 05 November 2014</span><br />
<span>Time: 11:30 AM PDT | 02:30 PM EDT</span><br />
<span>Duration: 75 Minutes</span><br />
<span>Price: $199.00 Live Session for one participant</span><br />
<span style="LINE-HEIGHT: 30px; COLOR: #cd0e20">Super combo offer Live + Training CD at $499.00</span></td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
While the FDA regulated industry has continued to rely on a compliance-based quality system, other industries have achieved far greater accomplishments satisfying customer needs and requirements. The 1978 medical device regulations began to break this mode by placing the responsibility of achieving customer requirements through management accountability and responsibility. ICH Q7A (2001) defines quality and production responsibilities with management responsibilities implied through internal audit. The 2006 FDA "Quality Systems Approach" further enhanced defining of responsibilities. Then, in 2008, ICH Q10 focused on the important role Of Senior Management Responsibility to direct resources to meet customer quality requirements.<br />
<br />
This webinar will discuss and analyze the differences between the above guidance documents and regulations, then show ways to document and implement these responsibilities. Merging and consolidation of these will be emphasized.<br />
<br />
<span><strong>Why Should you Attend:</strong></span>
<ul>
<li>By attending this webinar, you will gain a better understanding of the interdepartmental activities and their roles and interactions, in order to operate more effective, go beyond maintaining compliance, and improve these activities.</li>
<li>Assist in the preparation of policies and SOP's.</li>
</ul>
<span><strong>Objectives of the Presentation:</strong></span>
<ul>
<li>Introduction, Purpose and Background</li>
<li>RASCI-The Roles of Responsible, Accountable, Supportive, Consultative, & Informative</li>
<li>What is The Role of Responsibility?</li>
<li>The historical perspective of responsibility and accountability in the regulation of pharmaceuticals.</li>
<li>Direct & Implied Responsibilities In the Regulations and Guidance Documents-ICH Q10, Q7A, Part 210-211, & Part 606, & the FDA's Quality Systems Approach</li>
<li>Shifting roles-the "Brick & Mortar" vs "Virtual Company"</li>
<li>Roles and Responsibilities in the Product & The Manufacturing Lifecycles</li>
<li>Auditing existing system for compliance to requirements and identifying improvements for greater effectiveness</li>
<li>Using the quality manual to define and implement responsibility and accountability.</li>
<li>A quick and efficient technique to define responsibilities in an organization.</li>
<li>Handouts to illustrate the subject matter of this topic</li>
</ul>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="242"><span><strong>Who can Benefit:</strong></span><br />
This webinar will benefit all departments related to pharmaceutical industries. Below is a list professional who csn benefit from this webinar.
<ul>
<li>QA & QC</li>
<li>Senior Management</li>
<li>Research and Development</li>
<li>Regulatory Affairs</li>
<li>Senior & Junior Management</li>
<li>Purchasing & Finance</li>
<li>Engineering and Maintenance</li>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Howard T Cooper</strong><br />
President, EQACT,INC</td>
<td valign="top" width="45" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMa~wqiDv8S~xb~Gv8C~yIWSTsqsWf7QDGs_T7~Pv9l&2=35401"><img alt="Image" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/20544/howard_32_40.jpg" width="32" /></a></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which provided a very advanced and preventative approach toward quality systems. He quickly advanced to a managerial role experiencing responsibilities for quality management, quality system mitigation, and startup of new breweries. <a style="CURSOR: pointer; TEXT-DECORATION: underline"
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From: onlinecompliancepanel <hol...@rn...> - 2014-10-06 14:48:43
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<span style="FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #555555; FONT-SIZE: 10px; FONT-WEIGHT: normal">38868 Salmon Ter, Fremont California 94536</span><br />
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<span style="FONT-FAMILY: font-family: Verdana, Arial, Helvetica, sans-serif; COLOR: #215a9d; FONT-SIZE: 16px; TEXT-DECORATION: none" class="live">Live Webinar on</span></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #006398; FONT-SIZE: 20px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none; PADDING-TOP: 10px" height="auto" valign="top" width="460"><a class="topic" style="TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMa~wrTDv8S~xb~Gv8C~yJHSTsqsWf7QDEM_T7~Pv~F&2=34075">Supplier Qualification - Important Part of Quality Systems and Supply Chain Management</a></td>
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<td style="PADDING-BOTTOM: 10px; LINE-HEIGHT: 20px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #333333; FONT-SIZE: 11px; FONT-WEIGHT: bold; TEXT-DECORATION: none; PADDING-TOP: 0px" class="time" height="auto" valign="top" width="460"><span>Instructor: <a class="sub_head3" style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMa~wrTDv8S~xb~Gv8C~yJHSTsqsWf7QDEM_T7~Pv~F&2=34076">Kenneth Christie</a></span><br />
<span>Date: Thursday, October 30, 2014</span><br />
<span>Time: 10:00 AM PDT | 01:00 PM EDT</span><br />
<span>Duration: 90 Minutes</span><br />
<span>Price: $243.00 Live Session for one participant</span></td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
This webinar is important to the industry as all the regulations require quality assurance of the materials, components, and services that impact or are used for the final product configuration. In addition, supplier qualification is a critical portion of the quality system requirements (21 CFR 820), and companies must demonstrate control over their suppliers and the materials or services provided by them. This webinar will review the regulatory aspects of this program such as purchasing controls, evaluation of suppliers, contractors and consultants along with discussion of recent deficiencies found during their review by the inspectors.<br />
<br />
A common approach to defining the level of control for suppliers is a risk-based approach where the higher the risk, the greater the level of control exerted. This can then be translated into whether or not on-site audits, mail-in audits or no audits are required. The webinar will provide a check list of items to be evaluated when selecting a potential supplier, and the topics to be included in a supplier agreement to answer the questions of what, when, how and who. Attendees will be given ample opportunity to ask questions regarding their current approach or to share ideas for improvement.<br />
<br />
<span><strong>Why Should you Attend:</strong></span><br />
Attendees will walk away with not only the regulatory requirements for supplier agreements but a template of topics to use to evaluate or develop their own agreements.<br />
<br />
<span><strong>Objectives of the Presentation:</strong></span><br />
<ul>
<li>Current regulatory requirements for supplier agreements as found in 21 CFR 820.</li>
<li>Common topics to evaluate when conducting a risk-based supplier qualification.</li>
<li>Typical things that should be covered in supplier agreements and the quality standards that should be examined.</li>
<li>Review of the typical "tools" that companies should use to assure control of their suppliers and issues relating to the handling of changes.</li>
</ul>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="242"><span><strong>Who can Benefit:</strong></span><br />
<ul>
<li>Engineering</li>
<li>Manufacturing directors and supervisors</li>
<li>Supply Chain Personnel</li>
<li>Purchasing</li>
<li>cGMP auditors</li>
<li>QA/QC personnel</li>
</ul>
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<td style="PADDING-LEFT: 10px" class="content" height="35" valign="center" colspan="2" align="left"><strong>Instructor Profile:</strong></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Kenneth Christie</strong><br />
COO, VTS Consultants, Inc,</td>
<td valign="top" width="45" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMa~wrTDv8S~xb~Gv8C~yJHSTsqsWf7QDEM_T7~Pv~F&2=34078"><img alt="Image" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/22060/kenneth_32_40.jpg" width="32" /></a></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amhesrt, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices and solid dosage processing equipment, utilities, and systems on a global basis. <a style="CURSOR: pointer; TEXT-DECORATION: underline"
href="http://holkoi.custhelp.com/rd?1=AvMa~wrTDv8S~xb~Gv8C~yJHSTsqsWf7QDEM_T7~Pv~F&2=34079">More...</a></td>
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<span class="contentsox">Email:</span> <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="mailto:cus...@on...">cus...@on....</a><br />
<span class="contentsox">Call us at this Toll Free number: 510-857-5896<br />
Fax: 510-509-9659</span><br />
<span class="contentsox">Address: 38868 Salmon Ter, Fremont California 94536</span>
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From: onlinecompliancepanel <hol...@rn...> - 2014-10-01 15:23:37
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<td height="89" valign="center" width="310" align="center"><a style="TEXT-DECORATION: underline" target="_blank" href="http://holkoi.custhelp.com/rd?1=AvMc~wr4Dv8S~xb~Gv8E~yJsSTsqsWf7QDHd_T7~Pv8U&2=32770"><img alt="OCP_Logo" border="0" height="73" src="http://www.onlinecompliancepanel.com/images/Webinar_Mailer/OCP_Logo.jpg" width="297" /></a></td>
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<span style="FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #555555; FONT-SIZE: 10px; FONT-WEIGHT: normal">38868 Salmon Ter, Fremont California 94536</span><br />
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<span style="FONT-FAMILY: font-family: Verdana, Arial, Helvetica, sans-serif; COLOR: #215a9d; FONT-SIZE: 16px; TEXT-DECORATION: none" class="live">Live Webinar on</span></td>
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miss the chance</a></td>
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<span>Date: Wednesday, October 15, 2014</span><br />
<span>Time: 10:00 AM PDT | 01:00 PM EDT</span><br />
<span>Duration: 60 Minutes</span><br />
<span>Price:</span> <span style="TEXT-DECORATION: line-through">$243.00</span>   $235 Live Session for one participant<br />
<span style="LINE-HEIGHT: 30px; COLOR: #cd0e20">Super combo offer Live + Training CD at <span style="TEXT-DECORATION: line-through">$549.00</span> $439</span><br />
Offer valid till October 03, 2014</td>
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<td style="PADDING-BOTTOM: 0px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 10px" class="content" height="auto" valign="top" width="460"><span><strong>Webinar Description:</strong></span><br />
Written procedures are to be established and followed for a time efficient and clear evidence of the quality related elements during the review and approval for release, including packaging and labeling, to determine compliance of the intermediates (FDA definition) and/or finished product with established specifications before a batch can be released for distribution.<br />
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BPRs, DHRs and laboratory control records for critical process steps are to be reviewed and approved by the quality unit(s) before a finished product batch is released for distribution. Production and laboratory control records for earlier, non-critical process steps may be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s).<br />
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<span><strong>Why Should you Attend:</strong></span><br />
A vast majority of the current industry deficiencies which have led to isolated 483s, Warning Letters and Consent Decrees are the result of deficient technical documentation of the production processes for both injectables, devices and solid dosages.<br />
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Quality Systems require both Operations and Quality Departments to be unified with the overall intent of minimizing patient risk by documenting the process in a fashion that is technically accurate and easy to demonstrate that we are thinking and operating with the same objectives as the regulatory agencies are required to enforce.<br />
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<span><strong>Objectives of the Presentation:</strong></span>
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<li>Generation of BPRs, DHRs and SOPs to provide technically written instruction sets to eliminate operator errors. Training is NOT the primary means of generating and error free operation.</li>
<li>Production and In-Process Controls</li>
<li>Inspection, Packaging and Identification Labeling of Finished Products and Intermediates</li>
<li>Responsibilities for Production Activities</li>
<li>Data selection and entry into the statistical tracking from the BPR and DHR</li>
<li>Incident / Deviation Tracking along with Customer Complaints and CAPA changes</li>
<li>Annual Reports.</li>
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<td height="35" valign="center" width="218" align="center"><a class="reg1" style="FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #ffffff; FONT-SIZE: 17px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none" href="http://holkoi.custhelp.com/rd?1=AvMc~wr4Dv8S~xb~Gv8E~yJsSTsqsWf7QDHd_T7~Pv8U&2=32773">Register Now</a></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="242"><span><strong>Who can Benefit:</strong></span><br />
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<li>Quality and Documentation Personnel within the industry.</li>
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<td style="PADDING-LEFT: 10px" class="content" height="35" valign="center" colspan="2" align="left"><strong>Instructor Profile:</strong></td>
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<td style="PADDING-LEFT: 10px" class="content" height="auto" valign="top" width="197"><strong>Jerry Dalfors</strong><br />
Principal, JD Technologies,</td>
<td valign="top" width="45" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMc~wr4Dv8S~xb~Gv8E~yJsSTsqsWf7QDHd_T7~Pv8U&2=32774"><img alt="Image" border="0" height="40" src="http://www.onlinecompliancepanel.com/images/speakers/22194/dalfors_32_40.jpg" width="32" /></a></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 10px; PADDING-TOP: 0px" class="content" height="auto" valign="top" width="242">Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMc~wr4Dv8S~xb~Gv8E~yJsSTsqsWf7QDHd_T7~Pv8U&2=32775">More...</a></td>
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<td style="PADDING-LEFT: 10px" class="content" bgcolor="#FFFFFF" height="34" valign="center" width="299" align="left"><a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMc~wr4Dv8S~xb~Gv8E~yJsSTsqsWf7QDHd_T7~Pv8U&2=32776">About Us</a> | <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="mailto:cus...@on...">Email</a> | <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMc~wr4Dv8S~xb~Gv8E~yJsSTsqsWf7QDHd_T7~Pv8U&2=32777">Webinars</a></td>
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<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; PADDING-TOP: 10px" class="content" bgcolor="#EEEDED" height="auto" valign="top" colspan="2"><span class="content1"><strong class="contentsox">Customer Support :</strong></span><br />
<span class="contentsox">Email:</span> <a style="CURSOR: pointer; TEXT-DECORATION: underline" href="mailto:cus...@on...">cus...@on....</a><br />
<span class="contentsox">Call us at this Toll Free number: 510-857-5896<br />
Fax: 510-509-9659</span><br />
<span class="contentsox">Address: 38868 Salmon Ter, Fremont California 94536</span>
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