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[Openflow-dev] Get an overview of the updated ISO 13485 2016 standards
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From: 2016 I. T. <we...@em...> - 2016-04-04 14:49:14
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color: #ffffff; outline: none;">www.atozcompliance.com</a></strong></span></div> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> <table border="0" align="center" cellpadding="0" cellspacing="0" bgcolor="#FFFFFF" class="deviceWidth" style="margin: 0px auto; border: 1px solid #5b585a; width: 580px;"> <tbody> <tr> <td width="10" valign="top" bgcolor="#FFFFFF" style="padding: 0;"> </td> <td width="560" valign="top" bgcolor="#FFFFFF" style="padding: 0;"> <div><a href="http://emails.atozcompliance.com/cgi-bin28/DM/t/hb8l0Ce4FG0FMi0pj7R0Ez" target="_blank" style="text-decoration: none; color: #43b74a; outline: none; font-size: 24px; font-family: arial;"><span style="text-decoration: none; color: #43b74a; outline: none; font-size: 22px; font-family: arial;"><strong>Live Webinar: </strong></span><strong>ISO 13485 2016–Quality management systems - Requirements for regulatory purposes.</strong></a></div> </td> <td width="10" valign="top" bgcolor="#FFFFFF" style="padding: 0;"> </td> </tr> </tbody> </table> <table border="0" align="center" cellpadding="0" cellspacing="0" bordercolor="#FFFFFF" bgcolor="#FFFFFF" class="deviceWidth" style="margin: 0px auto; border: 1px solid #3a3a3a; width: 580px;"> <tbody> <tr> <td width="200" valign="top" bgcolor="#3A3A3A" style="padding: 0;"> <div> <table align="center"> <tbody> <tr> <td width="165"> <div><center><span style="text-decoration: none; font-size: 14px; color: #00cc33; font-family: Arial;"> <strong>Date: April 12, 2016</strong> </span></center></div> </td> </tr> </tbody> </table> </div> <div></div> </td> <td width="302" valign="top" bgcolor="#3A3A3A" style="padding: 0;"> <div> <table align="center"> <tbody> <tr> <td width="253"> <div><center><span style="text-decoration: none; font-size: 14px; color: #00cc33; font-family: Arial;"> <strong>Time: 1:00 PM EDT | 10:00 AM PDT</strong></span></center></div> </td> </tr> </tbody> </table> </div> </td> <td width="122" valign="top" bgcolor="#3A3A3A" style="padding: 0;"> <div> <table align="center" style="font-size: 16px; color: #000000; font-family: Arial;"> <tbody> <tr> <td width="62"> <div><center> <table border="1" align="left" bordercolor="#000000" bgcolor="#00CC33" style="width: 90px;"> <tbody> <tr> <td style="padding: 3px 3px;" align="center"><a href="http://emails.atozcompliance.com/cgi-bin28/DM/t/hb8l0Ce4FG0FMi0pj7S0E1" target="_blank" style="color: #0d0d0d; text-align: center; font-size: 12px;"><strong>Register Now</strong></a></td> </tr> </tbody> </table> </center></div> </td> </tr> </tbody> </table> </div> </td> </tr> </tbody> </table> <table border="0" align="center" cellpadding="0" cellspacing="0" bgcolor="#FFFFFF" class="deviceWidth" style="margin: 0px auto; border-top-width: 1px; border-top-style: solid; border-top-color: #5b585a; border-left-width: 1px; border-left-style: solid; border-left-color: #5b585a; border-right-width: 1px; border-right-style: solid; border-right-color: #5b585a; width: 580px;"> <tbody> <tr> <td class="center" style="padding: 10px 0 0 5px;"> <table border="0" cellpadding="0" cellspacing="0" align="left" class="deviceWidth" style="width: 100%;"> <tbody> <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></div> </td> <td valign="top"> <div> <div style="color: #067ee7; font-weight: bold; font-size: 16px;"> <p align="left" style="mso-table-lspace: 0; mso-table-rspace: 0; margin: 0;"><span style="color: #0d0d0d; font-weight: bold; font-size: 12px;">Dear Colleague,</span></p> <p align="left" style="mso-table-lspace: 0; mso-table-rspace: 0; margin: 0;"> </p> <p align="left" style="mso-table-lspace: 0; mso-table-rspace: 0; margin: 0;"><span style="font-family: Arial; color: #0d0d0d; line-height: 14px; font-weight: normal; font-size: 12px;">Our live webinar on April 12 is still open and available for you. </span><br> <br> </p> <p align="left" style="mso-table-lspace: 0; mso-table-rspace: 0; margin: 0;"><span style="color: #0d0d0d; font-weight: bold; font-size: 16px;">Know how Medical Device designers and manufacturers can follow ISO 13485 2016 to maintain their Quality management system processes in a state of control.</span></p> <div></div> </div> </div> </td> <td valign="top"> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> <!-- End 2 Column Images & Text Side by SIde --> <!-- spacer --> <!-- Two Column (Images Stacked over Text) --> <table border="0" align="center" cellpadding="0" cellspacing="0" bgcolor="#FFFFFF" class="deviceWidth" style="margin: 0px auto; border-left-width: 1px; border-left-style: solid; border-left-color: #5b585a; border-right-width: 1px; border-right-style: solid; border-right-color: #5b585a; width: 580px;"> <tbody> <tr> <td class="center" style="padding: 10px 0 0 5px;"> <table border="0" align="left" cellpadding="0" cellspacing="0" bordercolor="#EBEBEB" class="deviceWidth" style="width: 62%;"> <tbody> <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 align="left" style="mso-table-lspace: 0; mso-table-rspace: 0; margin: 0;"><span style="font-family: Arial; color: #0d0d0d; line-height: 14px; font-weight: normal; font-size: 12px;">Medical Device designers and manufacturers are required to follow ISO 13485 and will be expected to implement the 2016 revision changes. They will have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOP, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.<br> <br> The webinar will first present the key differences between ISO 13485 2016 versus ISO 13485 2003 and an overview of the updated standard. The changes to this standard will have profound implications to how Quality management systems interact internally and between different supply chain agents.<br> <br> It is better to understand what is coming and begin to plan for the changes that will permeate throughout all areas of your organization’s quality processes.<br> </span><b><br> <br> </b></p> <p align="left" style="mso-table-lspace: 0; mso-table-rspace: 0; margin: 0;"><span style="color: #0d0d0d; font-weight: bold; font-size: 16px;">Why it’s important for you to attend this webinar?</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>Regulatory requirements</li> <li>Risk-based approach</li> <li>Medical device file</li> <li>Design and development</li> <li>Process validation guidance</li> </ul> </td> </tr> </tbody> </table> <table border="0" align="left" cellpadding="0" cellspacing="0" bordercolor="#3A3A3A" bgcolor="#3A3A3A" class="deviceWidth" style="width: 36%;"> <tbody> <tr> <td colspan="3" height="5" align="left" valign="top"> <p style="mso-table-lspace: 0; mso-table-rspace: 0; margin: 0;"></p> </td> <td width="1%" rowspan="6"></td> </tr> <tr> <td align="center" valign="top"> </td> <td colspan="2" align="center" valign="top" bgcolor="#43B74A"><b><span style="font-size: 10.0pt; font-family: Arial; color: #ffffff;">Webinar Speaker Details</span></b></td> </tr> <tr align="left"> <td align="left" valign="top"> </td> <td align="left" valign="top"><img src="https://www.atozcompliance.com/img/frontend/speakers/prefix_Jose Mora.jpg" border="0" alt="José Mora" title="José Mora" width="81" height="72" align="left" name="square"></td> <td align="left" valign="top"> <div><span style="font-family: Arial; color: #ffffff; line-height: 16px; font-weight: bold; font-size: 11px;">José Mora, <br> Principal Consultant</span></div> </td> </tr> <tr> <td rowspan="2" align="center" valign="top"> </td> <td colspan="2" align="center" valign="top" bgcolor="#3A3A3A"><hr noshade="noshade"></td> </tr> <tr> <td colspan="2" align="center" valign="top" bgcolor="#43B74A"><b><span style="font-size: 10.0pt; font-family: Arial; color: #ffffff;">Upcoming Webinars</span></b></td> </tr> <tr> <td width="1%" align="center" valign="top"> </td> <td width="94%" colspan="2" align="center" valign="top"> <p align="left" style="mso-table-lspace: 0; mso-table-rspace: 0; margin: 0;"><span style="font-family: Arial; line-height: 16px; font-weight: bold; font-size: 12px; color: #ffffff;"><a href="http://emails.atozcompliance.com/cgi-bin28/DM/t/hb8l0Ce4FG0FMi0pj7T0E2" target="_blank"><span style="text-decoration: none; color: #ffffff; outline: none; font-size: 12px; font-family: arial;"><strong><u>How to perform a Remote Audit</u></strong></span> </a><br> </span><span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #ffffff;">Speaker:</span> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #43b74a;">Cinta Burgos</span> <br> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #ffffff;">Date:</span> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #43b74a;">April 21st, Thursday</span><br> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #ffffff;">Time:</span><span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #43b74a;"> 01:00 PM EDT</span><span style="font-family: Arial; line-height: 16px; font-weight: bold; font-size: 12px; color: #ffffff;"><br> </span><span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #ffffff;">Duration:</span> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #43b74a;">60 Minutes</span> </p> <hr noshade="noshade"> <p align="left" style="mso-table-lspace: 0; mso-table-rspace: 0; margin: 0;"><span style="font-family: Arial; line-height: 16px; font-weight: bold; font-size: 12px; color: #ffffff;"><a href="http://emails.atozcompliance.com/cgi-bin28/DM/t/hb8l0Ce4FG0FMi0pj7U0E3" target="_blank"><span style="text-decoration: none; color: #ffffff; outline: none; font-size: 12px; font-family: arial;"><strong><u>HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms</u></strong></span> </a><br> </span><span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #ffffff;">Speaker:</span><span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #43b74a;"> Roger Cowan</span><br> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #ffffff;">Date:</span> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #43b74a;">April 21st, Thursday</span><br> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #ffffff;">Time:</span> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #43b74a;">01:00 PM EDT</span> <span style="font-family: Arial; line-height: 16px; font-weight: bold; font-size: 12px; color: #ffffff;"><br> </span><span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #ffffff;">Duration:</span> <span style="font-family: Arial; line-height: 16px; font-size: 12px; color: #43b74a;">60 Minutes</span><br> </p> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> <table border="0" align="center" cellpadding="0" cellspacing="0" bgcolor="#FFFFFF" class="deviceWidth" style="margin: 0px auto; 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