Menu
▾
▴
[Openflow-dev] Handling and Processing of CGMP Controlled Raw Materials
|
From: onlinecompliancepanel W. <hol...@rn...> - 2014-11-13 15:39:02
|
<!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" xmlns:rn="http://schemas.rightnow.com/crm/document">
<head>
<title>cGMP Controlled Raw Materials</title>
<style type="text/css" xml:space="preserve">
/*<![CDATA[*/
BODY {
BACKGROUND-COLOR: #eeeeee
}
.border {
BORDER-BOTTOM: #cccccc 1px solid; BORDER-LEFT: #cccccc 1px solid; BACKGROUND-COLOR: #ffffff; BORDER-TOP: #cccccc 1px solid; BORDER-RIGHT: #cccccc 1px solid
}
A:link {
COLOR: #0033cc; CURSOR: pointer; TEXT-DECORATION: none
}
A:visited {
COLOR: #0033cc; CURSOR: pointer; TEXT-DECORATION: none
}
A:hover {
COLOR: #0099ff; CURSOR: pointer; TEXT-DECORATION: none
}
A:active {
COLOR: #0033cc; CURSOR: pointer; TEXT-DECORATION: none
}
A.a:link {
COLOR: #ffffff; CURSOR: pointer; TEXT-DECORATION: none
}
A.a:visited {
COLOR: #ffffff; CURSOR: pointer; TEXT-DECORATION: none
}
A.a:hover {
COLOR: #397df3; CURSOR: pointer; TEXT-DECORATION: none
}
A.a:active {
COLOR: #ffffff; CURSOR: pointer; TEXT-DECORATION: none
}
.call {
PADDING-RIGHT: 10px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #cd0e20; FONT-SIZE: 18px; FONT-WEIGHT: bold
}
.time {
LINE-HEIGHT: 20px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #333333; FONT-SIZE: 11px; FONT-WEIGHT: bold; TEXT-DECORATION: none
}
.sub_head3 {
FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #1b446f; FONT-SIZE: 12px; FONT-WEIGHT: bold
}
.content {
LINE-HEIGHT: 18px; FONT-FAMILY: verdana; COLOR: #666666; FONT-SIZE: 12px; TEXT-DECORATION: none
}
A.reg1:link {
FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #ffffff; FONT-SIZE: 17px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none
}
A.reg1:visited {
FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #ffffff; FONT-SIZE: 17px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none
}
A.reg1:hover {
FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #b7def3; FONT-SIZE: 17px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none
}
A.topic:link {
FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #006398; FONT-SIZE: 20px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none
}
A.topic:visited {
FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #006398; FONT-SIZE: 20px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none
}
A.topic:hover {
FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #006398; FONT-SIZE: 20px; CURSOR: pointer; FONT-WEIGHT: bold; TEXT-DECORATION: none
}
.live {
FONT-FAMILY: font-family: Verdana, Arial, Helvetica, sans-serif; COLOR: #215a9d; FONT-SIZE: 16px; TEXT-DECORATION: none
}
.offers {
PADDING-RIGHT: 10px; FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #cd0e20; FONT-SIZE: 12px; FONT-WEIGHT: normal
}
.style1 {
FONT-STYLE: italic; FONT-SIZE: 12px
}
/*]]>*/
</style>
</head>
<body>
<table style="BORDER-BOTTOM: #cccccc 1px solid; BORDER-LEFT: #cccccc 1px solid; BACKGROUND-COLOR: #ffffff; BORDER-TOP: #cccccc 1px solid; BORDER-RIGHT: #cccccc 1px solid" class="border" border="0" cellspacing="0" cellpadding="0" width="700" align="center"><!--DWLayoutTable-->
<tbody>
<tr>
<td height="90" valign="top" colspan="2">
<table style="BORDER-BOTTOM: #cccccc 1px solid" border="0" cellspacing="0" cellpadding="0" width="100%"><!--DWLayoutTable-->
<tbody>
<tr>
<td height="89" valign="top" width="310">
<table border="0" cellspacing="0" cellpadding="0" width="100%"><!--DWLayoutTable-->
<tbody>
<tr>
<td height="89" valign="center" width="310" align="center"><a style="TEXT-DECORATION: underline" target="_blank" href="http://holkoi.custhelp.com/rd?1=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=49182"><img alt="OCP_Logo" border="0" height="73" src="http://www.onlinecompliancepanel.com/images/Webinar_Mailer/OCP_Logo.jpg" width="297" /></a></td>
</tr>
</tbody>
</table>
</td>
<td valign="top" width="388">
<table border="0" cellspacing="0" cellpadding="0" width="100%"><!--DWLayoutTable-->
<tbody>
<tr>
<td class="call" height="89" valign="center" width="388" align="right"><span style="FONT-FAMILY: Verdana, Arial, Helvetica, sans-serif; COLOR: #cd0e20; FONT-SIZE: 18px; FONT-WEIGHT: bold">Toll Free: 510-857-5896</span><br />
<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 />
<br />
<span class="style1">Live Webinar</span></td>
</tr>
</tbody>
</table>
</td>
</tr>
</tbody>
</table>
</td>
</tr>
<tr>
<td height="77" valign="top" colspan="2">
<table border="0" cellspacing="0" cellpadding="0" width="100%"><!--DWLayoutTable-->
<tbody>
<tr>
<td bgcolor="#FF9900" height="77" valign="top" width="692"><img alt="HAPPY THANKSGIVING DAY" height="77" src="http://www.onlinecompliancepanel.com/images/ocp/ocp_thanksgiving.jpg" width="700" /></td>
</tr>
</tbody>
</table>
</td>
</tr>
<tr>
<td height="37" valign="top" colspan="2">
<table border="0" cellspacing="0" cellpadding="0" width="100%" bgcolor="#FFFFFF"><!--DWLayoutTable-->
<tbody>
<tr>
<td style="BORDER-BOTTOM: #cccccc 1px solid" bgcolor="#FFFFCC" height="37" valign="center" width="698" align="center"><span style="TEXT-ALIGN: center; FONT-FAMILY: Arial, Helvetica, sans-serif; COLOR: #e62022; FONT-SIZE: 13px; FONT-WEIGHT: bold">Last few seats available for the Exclusive webinar on</span></td>
</tr>
</tbody>
</table>
</td>
</tr>
<tr>
<td height="0" valign="top" colspan="2">
<table border="0" cellspacing="0" cellpadding="0" width="100%"><!--DWLayoutTable-->
<tbody>
<tr>
<td style="PADDING-BOTTOM: 10px; PADDING-LEFT: 10px; PADDING-RIGHT: 0px; PADDING-TOP: 10px" height="auto" valign="center" width="697" align="center"><a class="topic" style="TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=49183">cGMP Controlled Raw Materials</a></td>
</tr>
</tbody>
</table>
</td>
</tr>
<tr>
<td valign="top" rowspan="2" width="700">
<table style="BORDER-BOTTOM: #cccccc 1px" border="0" cellspacing="0" cellpadding="0" width="100%" height="321"><!--DWLayoutTable-->
<tbody>
<tr>
<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: normal; TEXT-DECORATION: none; PADDING-TOP: 0px" class="time" height="321" valign="top" width="357">
<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>
<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; TEXT-DECORATION: none; PADDING-TOP: 0px" class="content" valign="top" width="343">
<table style="MARGIN-TOP: 10px" border="0" cellspacing="0" cellpadding="0" width="94%" bgcolor="#EEEDED"><!--DWLayoutTable-->
<tbody>
<tr>
<td height="auto" valign="top" width="344">
<table style="BORDER-BOTTOM: #afafaf 1px solid; BORDER-LEFT: #afafaf 1px solid; MARGIN: 10px; BORDER-TOP: #afafaf 1px solid; BORDER-RIGHT: #afafaf 1px solid" border="0" cellspacing="0" cellpadding="0" width="302" bgcolor="#FFA717"><!--DWLayoutTable-->
<tbody>
<tr>
<td height="35" valign="center" colspan="3" 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=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=49185">Register Now</a></td>
<td width="1"></td>
</tr>
</tbody>
</table>
<table border="0" cellspacing="0" cellpadding="0" width="94%"><!--DWLayoutTable-->
<tbody>
<tr>
<td style="PADDING-LEFT: 10px" class="content" height="35" valign="center" colspan="2" align="left"><strong>Instructor Profile:</strong></td>
</tr>
<tr>
<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>
</tr>
</tbody>
</table>
</td>
</tr>
<tr>
<td height="auto" valign="top">
<table border="0" cellspacing="0" cellpadding="0" width="94%"><!--DWLayoutTable-->
<tbody>
<tr>
<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>
</tr>
</tbody>
</table>
</td>
</tr>
</tbody>
</table>
</td>
</tr>
</tbody>
</table>
<table style="BORDER-BOTTOM: #cccccc 1px solid" border="0" cellspacing="0" cellpadding="0" width="100%"><!--DWLayoutTable-->
<tbody>
<tr>
<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 />
<br /></td>
</tr>
<!--DWLayoutTable-->
<tr>
<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>
</ul>
</td>
<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>
</ul>
</td>
</tr>
<tr bgcolor="#FFA717">
<td height="38" valign="center" colspan="3" 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=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=49188">Register Now</a></td>
</tr>
<tr>
<td height="auto" valign="top" colspan="2">
<table style="BORDER-TOP: #cccccc 1px solid" border="0" cellspacing="0" cellpadding="0" width="100%"><!--DWLayoutTable-->
<tbody>
<tr>
<td style="PADDING-LEFT: 10px" class="content" bgcolor="#FFFFFF" height="34" valign="center" width="345" align="left"><a style="COLOR: #ea0e00; CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=49189">About Us</a> | <a style="COLOR: #ea0e00; CURSOR: pointer; TEXT-DECORATION: underline" href="mailto:cus...@on...">Email</a> | <a style="COLOR: #ea0e00; CURSOR: pointer; TEXT-DECORATION: underline" href="http://holkoi.custhelp.com/rd?1=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=49190">Webinars</a></td>
<td valign="center" width="353" align="right"><span class="offers">For more offers please contact customer support.</span></td>
</tr>
<tr>
<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>
<p class="contentsmall">If you do not wish to receive this training alerts from OnlineCompliancePanel Click <a target="_self" href="http://holkoi.custhelp.com/cgi-bin/holkoi.cfg/php/ma/unsub.php?1=AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W&2=100025&3=3">Unsubscribe</a></p>
</td>
</tr>
</tbody>
</table>
</td>
</tr>
</tbody>
</table>
</td>
</tr>
</tbody>
</table>
<img alt="" height="1" width="1" style="display: none" src="http://holkoi.custhelp.com/rd/AvMu~wpIDv8S~xb~Gv80~yK9STsqsWf7QDFf_T7~Pv_W.gif"/> </body>
</html>
|
