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[Openflow-dev] What to expect during an FDA / EU inspection.
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From: FDA U. T. <tra...@em...> - 2015-12-16 15:50:46
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color: #00CCFF; outline:none;font-size: 12px;">ad...@co...</a></div></td> </tr> <tr> <td width="297" valign="middle" bgcolor="#202022" style="padding:0"> </td> <td valign="top" bgcolor="#202022" style="padding:0"> </td> </tr> </table> <table width="580" border="0" align="center" cellpadding="0" cellspacing="0" bordercolor="#CCCCCC" bgcolor="#D8DF20" class="deviceWidth" style="margin:0 auto;"> <tr> <td width="10" valign="top" bgcolor="#D8DF20" style="padding:0"> </td> <td width="560" valign="top" bgcolor="#D8DF20" style="padding:0"><div align="left"><a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/ha4x0Ce4FG0ES60pZ4W0E7" target="_blank" style="text-decoration:none; color:#0D0D0D; outline:none; font-size: 24px; font-weight: bold;">FDA / EU Inspections - Getting Prepared.</a></div></td> <td width="10" valign="top" bgcolor="#D8DF20" style="padding:0"> </td> </tr> </table> <table width="580" border="0" align="center" cellpadding="0" cellspacing="0" bordercolor="#CCCCCC" bgcolor="#56CBF6" class="deviceWidth" style="margin:0 auto;"> <tr> <td width="154" valign="top" bgcolor="#56CBF6" style="padding:0"><div align="left"> <table align="center" style="font-size:16px; color:#000000; font-family:Arial"> <tr> <td width="253" style="font-size:16px; color:#56CBF6; font-family:Arial"><div align="center" ><span style="text-decoration: none; font-size: 16px; color: #0D0D0D; font-family:Arial, Verdana, Tahoma;">Time: 1.00 PM EDT</span></div></td> </tr> </table> </div> <div align="center"></div></td> <td width="1" valign="top" bgcolor="#eeeeed" style="padding:0"><div align="center"></div></td> <td width="264" valign="top" bgcolor="#56CBF6" style="padding:0"> <div align="center"> <table align="center" style="font-size:16px; color:#000000; font-family:Arial"> <tr> <td width="253" style="font-size:16px; color:#56CBF6; font-family:Arial"><div align="center"><span style="text-decoration: none; font-size: 16px; color: #0D0D0D; font-family:Arial, Verdana, Tahoma;">Date: January 07, 2016</span></div></td> </tr> </table> </div></td> <td width="1" valign="top" bgcolor="#eeeeed" style="padding:0"><div align="center"></div></td> <td width="159" valign="top" bgcolor="#56CBF6" style="padding:0"><div align="center"> <table align="center" style="font-size:16px; color:#000000; font-family:Arial"> <tr> <td width="253" style="font-size:16px; color:#56CBF6; font-family:Arial"><div align="center" ><span style="text-decoration: none; font-size: 16px; color: #0D0D0D; font-family:Arial, Verdana, Tahoma;">Duration: 60 Minutes</span></div></td> </tr> </table> </div></td> </tr> </table> <table width="580" border="1" align="center" cellpadding="0" cellspacing="0" bordercolor="#CCCCCC" bgcolor="#FFFFFF" class="deviceWidth" style="margin:0 auto;"> <tr> <td class="center" style="padding:10px 0 0 5px"><table width="100%" border="0" cellpadding="0" cellspacing="0" align="left" class="deviceWidth"> <tr> <td valign="top"><!-- The paragraph tag is important here to ensure that this table floats properly in Outlook 2007, 2010, and 2013 To learn more about this fix check out this link: https://www.emailonacid.com/blog/details/C13/removing_unwanted_spacing_or_gaps_between_tables_in_outlook_2007_2010 This fix is used for all floating tables in this responsive template The margin set to 0 is for Gmail --> <div align="left"><br> </div></td> <td valign="top"><div align="left"><span style="color: #0D0D0D; font-weight: bold; font-size: 16px;">Get a comparative look at FDA & EU GCP regulations to help understand the FDA and EU inspection process.</span></div></td> <td valign="top"> </td> </tr> </table></td> </tr> </table> <table width="580" border="1" align="center" cellpadding="0" cellspacing="0" bordercolor="#CCCCCC" bgcolor="#FFFFFF" class="deviceWidth" style="margin:0 auto;"> <tr> <td width="74" valign="top" bgcolor="#FFFFFF" style="padding:0"><div align="center"><img src="https://complianceglobal.us/img/frontend/speakers/55e4cffa51954.jpg" border="0" alt="Marie Dorat" title="Marie Dorat" name="circle" id="circle" width="81" height="72"/></div></td> <td width="348" valign="middle" bgcolor="#FFFFFF" style="padding:0"><div align="center"> <table align="center"> <tr> <td valign="top" style="padding:0 10px 0 5px"><div align="center"><span style="color: #067ee7; font-weight: bold; font-size: 16px;">Speaker: Marie Dorat</span><br /> LIVE ONLINE WEBINAR @<span style="color: #FF0000; font-weight: bold; font-size: 16px;"><span style='color'><del>$155</del></span></span> <span style="color:#067ee7;font-weight: bold; font-size: 16px;"> $125</span></div></td> </tr> </table> </div> <div align="left"></div></td> <td width="150" valign="middle" bgcolor="#FFFFFF" style="padding:0"><div align="left"> <table width="130" align="center" bordercolor="#FFFFFF" bgcolor="#CFDF1A" style="border-top-left-radius:4px; border-bottom-left-radius:4px;border-top-right-radius:4px; border-bottom-right-radius:4px;"> <tr> <td style="padding:3px 6px;" align="center"><a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/ha4x0Ce4FG0ES60pZ4X0E8" target="_blank" style="color: #0D0D0D; text-align: center; font-family:Tahoma;"><strong>Register Now</strong></a> </td> </tr> </table> </div></td> </tr> </table> <!-- End One Column --> <!-- 2 Column Images & Text Side by SIde --> <table width="580" border="1" align="center" cellpadding="0" cellspacing="0" bordercolor="#CCCCCC" bgcolor="#FFFFFF" class="deviceWidth" style="margin:0 auto;"> <tr> <td class="center" style="padding:10px 0 0 5px"><table width="100%" border="0" cellpadding="0" cellspacing="0" align="left" class="deviceWidth"> <tr> <td valign="top"><!-- The paragraph tag is important here to ensure that this table floats properly in Outlook 2007, 2010, and 2013 To learn more about this fix check out this link: https://www.emailonacid.com/blog/details/C13/removing_unwanted_spacing_or_gaps_between_tables_in_outlook_2007_2010 This fix is used for all floating tables in this responsive template The margin set to 0 is for Gmail --> <div align="left"><br> </div></td> <td valign="top"><div align="left"> <div align="left" style="color: #067ee7; font-weight: bold; font-size: 16px;">Overview:</div> <span style="font-family:Arial, Verdana, Tahoma; color: #0D0D0D; line-height: 16px; font-weight: normal;font-size: 12px;">This webinar is a comparative look at FDA & EU regulations to help attendees understand the FDA and EU inspection process and how to prepare for both of them. Attendees will learn the best practices to respond to Form 483 citations, Warning Letters and EU inspection findings. This webinar has been specifically designed to help attendees prepare for FDA and EU inspection. It will provide a background and understanding of the role played by the regulatory inspectors, and the administrative and enforcement powers. Attendees will be taken through the key stages of FDA and EU inspection processes and understands the various types of inspections that can be carried out. <a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/ha4x0Ce4FG0ES60pZ4Z0EB" target="_blank" style="text-decoration:none; color:#067ee7; outline:none;font-size:14px; "><b>Read more...</b></a></span></div></td> <td valign="top"> </td> </tr> </table> </td> </tr> </table> <!-- End 2 Column Images & Text Side by SIde --> <!-- spacer --> <!-- Two Column (Images Stacked over Text) --> <table width="580" border="1" align="center" cellpadding="0" cellspacing="0" bordercolor="#CCCCCC" bgcolor="#FFFFFF" class="deviceWidth" style="margin:0 auto;"> <tr> <td class="center" style="padding:10px 0 0 5px"> <table width="49%" border="0" cellpadding="0" cellspacing="0" align="left" class="deviceWidth"> <tr> <td align="center" valign="top"> <!-- The paragraph tag is important here to ensure that this table floats properly in Outlook 2007, 2010, and 2013 To learn more about this fix check out this link: https://www.emailonacid.com/blog/details/C13/removing_unwanted_spacing_or_gaps_between_tables_in_outlook_2007_2010 This fix is used for all floating tables in this responsive template The margin set to 0 is for Gmail --> <p style="mso-table-lspace:0;mso-table-rspace:0; margin:0"><span style="color: #067ee7; font-weight: bold; font-size: 16px;">How does it benefit you?<br></span></p> <ul style="font-family:Arial, Verdana, Tahoma; color: #0D0D0D; line-height: 18px; font-size: 12px; font-weight: normal; text-align: left; margin-bottom: 3px; margin-top: 5px;"> <li>What to expect during an FDA/EU inspection </li> <li>How to be prepared – with special focus on GCP inspections</li> <li>How to interact with the inspectors—DOs and DON’Ts</li> <li>How to reply to inspection reports, form 483 fda’s and EU inspection finding</li> <li>Post inspection actions – implementing appropriate CAPAs in response to audit findings</li> </ul> </td> </tr> </table> <table width="49%" border="0" cellpadding="0" cellspacing="0" align="left" class="deviceWidth"> <tr> <td align="center" valign="top"> <p style="mso-table-lspace:0;mso-table-rspace:0; margin:0"><a href="#" style="text-decoration: none; font-size: 14px; color: #0D0D0D; font-weight: bold; font-family:Arial, Verdana, Tahoma;"><span style="color: #067ee7; font-weight: bold; font-size: 16px;">Who needs to attend?</span></a></p> <ul style="font-family:Arial, Verdana, Tahoma; color: #0D0D0D; line-height: 18px; font-size: 12px; font-weight: normal; text-align: left; margin-bottom: 3px; margin-top: 5px;"> <li>Quality Assurance Managers and Auditors</li> <li>Regulatory Affairs Personnel</li> <li>Document Management Professionals</li> <li>Other Professionals who want to know more about inspection guidelines</li> </ul></td> </tr> </table> </td> </tr> </table> <table width="580" border="1" align="center" cellpadding="0" cellspacing="0" bordercolor="#CCCCCC" bgcolor="#FFFFFF" class="deviceWidth" style="margin:0 auto;"> <tr> <td class="center" style="padding:10px 0 0 5px"><table width="100%" border="0" cellpadding="0" cellspacing="0" align="left" class="deviceWidth"> <tr> <td valign="top"><!-- The paragraph tag is important here to ensure that this table floats properly in Outlook 2007, 2010, and 2013 To learn more about this fix check out this link: https://www.emailonacid.com/blog/details/C13/removing_unwanted_spacing_or_gaps_between_tables_in_outlook_2007_2010 This fix is used for all floating tables in this responsive template The margin set to 0 is for Gmail --> <div align="left"><span style="color: #067ee7; font-weight: bold; font-size: 16px;">Speaker expertise:</span> </div> <div span style="font-family:Arial, Verdana, Tahoma; color: #0D0D0D; line-height: 16px; font-size: 12px;font-weight: normal;"> <div align="left"><strong>Marie Dorat</strong>, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry. She also is the CEO of IPRF, LLC. <a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/ha4x0Ce4FG0ES60pZ4b0EJ" target="_blank" style="text-decoration:none; color:#067ee7; outline:none; font-size:14px;"><b>Read more...</b></a></div> </div></td> </tr> </table></td> </tr> </table> <table width="580" border="1" align="center" cellpadding="0" cellspacing="0" bordercolor="#CCCCCC" bgcolor="#FFFFFF" class="deviceWidth" style="margin:0 auto;"> <tr> <td class="center" style="padding:10px 0 0 5px"><table width="100%" border="0" cellpadding="0" cellspacing="0" align="left" class="deviceWidth"> <tr> <td valign="top"><!-- The paragraph tag is important here to ensure that this table floats properly in Outlook 2007, 2010, and 2013 To learn more about this fix check out this link: https://www.emailonacid.com/blog/details/C13/removing_unwanted_spacing_or_gaps_between_tables_in_outlook_2007_2010 This fix is used for all floating tables in this responsive template The margin set to 0 is for Gmail --><div align="left"><span style="color: #067ee7; font-weight: bold; font-size: 16px;">Registration Information:</span> </div> <div align="left"><span style="font-family: Arial; color: #0D0D0D; line-height: 14px; font-weight: normal;font-size: 12px;">Call our <a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/ha4x0Ce4FG0ES60pZ4d0EL" target="_blank" style="color: #067ee7; font-weight: bold; font-size: 14px;">Customer Support</a> at +1-844-746-4244 to avail the above discounted price or <span style="font-family: Arial; color: #0D0D0D; line-height: 16px; font-size: 12px;font-weight: normal;">Register <a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/ha4x0Ce4FG0ES60pZ4f0EN" target="_blank" style="color: #067ee7; font-weight: bold; font-size: 14px;">Online</a></span>. To register a group to attend the webinar at a discounted price or if you wish to pay by Check or PO; call us at +1-516-900-5515 or Fax us on +1-516-900-5510.</span><br> </div></td> </tr> </table></td> </tr> </table> <table width="580" border="0" align="center" cellpadding="0" cellspacing="0" bordercolor="#FFFFFF" bgcolor="#eeeeed" class="deviceWidth" style="margin:0 auto;"> <tr> <td valign="top" bgcolor="#FFFFFF" style="padding:0"><div align="left"> <div align="center"> <table align="center"> <tr> <td valign="top" style="padding:0 10px 10px 0"><span style="font-family:Arial, Verdana, Tahoma; color: #0D0D0D; line-height: 16px; font-weight: normal;font-size: 12px;">If you do not wish to receive further such emails from Compliance Global; please click <a href="http://emails.complianceglobal.us/cgi-bin28/DM/t/ha4x0Ce4FG0ES60pZ4V0E6?dm_params=JkVtYWlsQWRkcj1vcGVuZmxvdy1kZXZAbGlzdHMuc291cmNlZm9yZ2UubmV0JkRNQUlMVkFSX1VOU1VCPTFhbWNhaWFhYnBrMnFkNGxqZWpsaGRjY2JhbXpx&dm_params_sha256=f463bae0afbf4d44aa2ada37e55436d6f8910fd9dbfd6d98b92ff2a559056cc1" target="_blank" style="color: #FF0000"><b>Unsubscribe</b></a></span></td> </tr> </table> <table align="center"> <tr> <td valign="top" style="padding:0 10px 10px 0"><div align="center"><span style="font-family:Arial, Verdana, Tahoma; color: #0D0D0D; line-height: 16px; font-weight: normal;font-size: 12px;">Copyright © 2015 Compliance Global </span><br> <span style="font-family:Arial, Verdana, Tahoma; color: #0D0D0D; line-height: 16px; font-weight: normal;font-size: 12px;"> Compliance Global </span><span style="font-family:Arial, Verdana, Tahoma; color: #0D0D0D; line-height: 16px; font-weight: normal;font-size: 12px;"><br> 2754 80th Avenue, New Hyde Park, NY 11040</span></div></td> </tr> </table> </div> <div align="center"></div> </div></td> </tr> </table> <!-- End Two Column (Images Stacked over Text) --> <!-- Dark Background, Three Column Images --> <!-- 3 Small Images --> <!-- End 3 Small Images --> <!-- Dark Background, Three Column Images --> <!-- 2 Column Images - text left --> <!-- Blog Headlines --> <!-- end blog headlines --> <!-- spacer --> <!-- 4 Columns --> <table width="100%" border="0" cellpadding="0" cellspacing="0" align="center"> </table><!-- End 4 Columns --> </td> </tr> </table> <!-- End Wrapper --> <div style="display:none; white-space:nowrap; font:15px courier; color:#ffffff;"> - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - </div> </body> <IMG SRC="http://emails.complianceglobal.us/cgi-bin28/flosensing?z=a4x0Ce4FG0ES60Ba"></html> |
