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Content preview: 3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs Live Webinar | Speaker: John E Lincoln Date: Jun 29, 2022 | Time: 01 : 00 PM EST | Duration: 180 Minutes Content analysis details: (4.9 points, 8.0 required) pts rule name description ---- ---------------------- -------------------------------------------------- -0.5 BAYES_05 BODY: Bayes spam probability is 1 to 5% [score: 0.0231] 0.2 HEADER_FROM_DIFFERENT_DOMAINS From and EnvelopeFrom 2nd level mail domains are different -0.0 SPF_PASS SPF: sender matches SPF record 0.0 HTML_MESSAGE BODY: HTML included in message -0.1 DKIM_VALID_AU Message has a valid DKIM or DK signature from author's domain 0.1 DKIM_SIGNED Message has a DKIM or DK signature, not necessarily valid -0.1 DKIM_VALID Message has at least one valid DKIM or DK signature 1.8 PYZOR_CHECK Listed in Pyzor (https://pyzor.readthedocs.io/en/latest/) 3.5 KAM_WEBINAR Spam for webinars -0.0 T_SCC_BODY_TEXT_LINE No description available. X-Spam-Flag: NO This is a multi-part message in MIME format. --B15WVlKuAboc=_?: Content-Type: text/plain; charset="utf-8" Content-Transfer-Encoding: 8bit 3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs Live Webinar | Speaker: John E Lincoln Date: Jun 29, 2022 | Time: 01 : 00 PM EST | Duration: 180 Minutes https://click.info.mailssenders.com/?qs=f7c8f47312ae8ef36840d5194114c4bbf314e565ec668acafd6c01f83b8c5e9c45d255ba5d7776fbd068de79b711095eb47632831e143f6b Register Now This seminar will examine the existing requirements for theUS FDA's DHF including its derivative documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and its Technical Documentation File requirements, and evaluate the documents' differing purposes/goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation/update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical Document File Table of Contents; The importance and usefulness of the old "Essential Requirements", now "General Safety and Performance Requirements" and a suggested matrix format; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file inspections/audits by the FDA and Notified Bodies will be discussed. Areas Covered:- - The EU's MDR and the Technical Documentation File - Design Contol vs. a Product 'Snapshot in Time' - DHF "Typical" Contents - The DMR and DHR / Lot / Batch Record - Technical File Expected Contents - Focus on the General Safety and Performance Requirements and Why - Parallel Approaches to Documentation Teams - FDA and NB Audit Focus Why Should you Attend:- One of our most popular webinars, updated with the latest FDA and EU requirements. As U.S. companies go global, they must meet other product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). ISO 13485 mandates the same, a Design and Development File, per 7.3, which is now to be part of the EU's MDR-required documentation. In order to sell globally, the EU's CE-marking documentation is a requirement of the Technical Documentation file. Currently, they serve different purposes and support different goals, but their roles do overlap. And how/where do the DMR and DHR fit? Awareness of the similarities and differences can further concurrent development and/or updates to both, especially for companies marketing (or planning to) on both sides of the Atlantic. For more for 6+ attendees call us at +1-844-899-4647 or mail us at cs@profeducations.com https://click.info.mailssenders.com/?qs=f7c8f47312ae8ef37eda9ca99a72bda071d93cc632080e0abd5e2bef3d7a8100aa98120bd63e84e8ce3f9d3bdfd5d60c507956962479084b Click Here to download our Order Form If you don't want to hear from us https://click.info.mailssenders.com/unsub_center.aspx?qs=e91042b99e10ad788038822910a76b41dcce32056e2dedaa8887ac0874b7cd7c5993bdeb443457ba9c9e4ee676369d774e1ffb20c478a644625a16866f4c6027a3c84c21848f3217 Unsubscribe --B15WVlKuAboc=_?: Content-Type: text/html; charset="utf-8" Content-Transfer-Encoding: 8bit <!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"> <html> <head> <meta name="viewport" content="width=device-width, initial-scale=1, maximum-scale=1, user-scalable=0" /> <meta http-equiv="Content-Type" content="text/html; charset=UTF-8" /> <style type="text/css"> ReadMsgBody{ width: 100%;} .ExternalClass {width: 100%;} .ExternalClass, .ExternalClass p, .ExternalClass span, .ExternalClass font, .ExternalClass td, .ExternalClass div {line-height: 100%;} body {-webkit-text-size-adjust:100%; 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" class="stylingblock-content-wrapper"><tr><td class="stylingblock-content-wrapper camarker-inner"><p style="text-align: center; line-height: 1.15;"><strong><span style="color: rgb(0, 0, 0); font-size: 18px;">3-Hour Virtual Seminar on U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs</span></strong></p> <p style="text-align: center; line-height: 1;"><strong><span style="color: rgb(0, 0, 0); font-size: 18px; font-family: Arial, Helvetica, sans-serif;">Live Webinar | </span><span style="color: rgb(184, 49, 47); font-size: 18px; font-family: Arial, Helvetica, sans-serif;">Speaker:</span><span style="color: rgb(0, 0, 0); font-size: 18px; font-family: Arial, Helvetica, sans-serif;"> </span></strong><span style="font-family: Arial, Helvetica, sans-serif; font-size: 18px;">John E Lincoln</span></p> <p style="text-align: center;"><span style="color: rgb(184, 49, 47); font-size: 18px; font-family: Arial, Helvetica, sans-serif;"><strong>Date:</strong></span><span style="color: rgb(0, 0, 0); font-size: 18px; font-family: Arial, Helvetica, sans-serif;"><strong> </strong><strong>Jun 29, 2022</strong></span><span style="font-family: Arial, Helvetica, sans-serif;"><span style="color: rgb(0, 0, 0); font-size: 18px;"><strong> | </strong></span><span style="color: rgb(184, 49, 47); font-size: 18px;"><strong>Time:</strong></span><span style="color: rgb(0, 0, 0); font-size: 18px;"><strong> </strong></span></span><span style="color: rgb(0, 0, 0); font-size: 18px; font-family: Arial, Helvetica, sans-serif;"><strong>01 : 00 PM EST | </strong></span> <span style="color: rgb(184, 49, 47); font-size: 18px; font-family: Arial, Helvetica, sans-serif;"><strong>Duration:</strong></span><span style="color: rgb(0, 0, 0); font-size: 18px; font-family: Arial, Helvetica, sans-serif;"><strong> </strong></span><span style="font-size: 18px; font-family: Arial, Helvetica, sans-serif;"><strong>180 Minutes</strong></span></p> <hr style="height:3px;width:70%;color:red;background-color:red;"> <p style="text-align: center;"><span style="font-size: 20px;"><a href="https://click.info.mailssenders.com/?qs=f7c8f47312ae8ef36840d5194114c4bbf314e565ec668acafd6c01f83b8c5e9c45d255ba5d7776fbd068de79b711095eb47632831e143f6b"><strong>Register Now</strong></a></span></p> <hr> <hr> <p><span style="font-family: Georgia, serif; color: rgb(0, 0, 0);">This seminar will examine the existing requirements for theUS FDA's DHF including its derivative documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and its Technical Documentation File requirements, and evaluate the documents' differing purposes/goals.</span></p> <p><span style="font-family: Georgia, serif; color: rgb(0, 0, 0);">Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation/update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical Document File Table of Contents; The importance and usefulness of the old "Essential Requirements", now "General Safety and Performance Requirements" and a suggested matrix format; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file inspections/audits by the FDA and Notified Bodies will be discussed.</span></p> <p><span style="font-family: Georgia, serif; color: rgb(0, 0, 0);"><strong>Areas Covered:-</strong></span></p> <ul> <li style="font-family: Georgia, serif; color: rgb(0, 0, 0);">The EU's MDR and the Technical Documentation File</li> <li style="font-family: Georgia, serif; color: rgb(0, 0, 0);">Design Contol vs. a Product 'Snapshot in Time'</li> <li style="font-family: Georgia, serif; color: rgb(0, 0, 0);">DHF "Typical" Contents</li> <li style="font-family: Georgia, serif; color: rgb(0, 0, 0);">The DMR and DHR / Lot / Batch Record</li> <li style="font-family: Georgia, serif; color: rgb(0, 0, 0);">Technical File Expected Contents</li> <li style="font-family: Georgia, serif; color: rgb(0, 0, 0);">Focus on the General Safety and Performance Requirements and Why</li> <li style="font-family: Georgia, serif; color: rgb(0, 0, 0);">Parallel Approaches to Documentation Teams</li> <li style="font-family: Georgia, serif; color: rgb(0, 0, 0);">FDA and NB Audit Focus</li> </ul> <p><span style="font-family: Georgia, serif; color: rgb(0, 0, 0);"><strong>Why Should you Attend:-</strong></span></p> <p><span style="font-family: Georgia, serif; color: rgb(0, 0, 0);">One of our most popular webinars, updated with the latest FDA and EU requirements. As U.S. companies go global, they must meet other product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). ISO 13485 mandates the same, a Design and Development File, per 7.3, which is now to be part of the EU's MDR-required documentation.</span></p> <p><span style="font-family: Georgia, serif; color: rgb(0, 0, 0);">In order to sell globally, the EU's CE-marking documentation is a requirement of the Technical Documentation file. Currently, they serve different purposes and support different goals, but their roles do overlap. And how/where do the DMR and DHR fit? Awareness of the similarities and differences can further concurrent development and/or updates to both, especially for companies marketing (or planning to) on both sides of the Atlantic.</span></p> <hr> <p style="text-align: center;"><strong><span style="font-size: 17px;">For more for 6+ attendees call us at +1-844-899-4647 or mail us at cs@profeducations.com</span></strong></p> <hr> <p style="text-align: center;"> <a href="https://click.info.mailssenders.com/?qs=f7c8f47312ae8ef37eda9ca99a72bda071d93cc632080e0abd5e2bef3d7a8100aa98120bd63e84e8ce3f9d3bdfd5d60c507956962479084b"><strong>Click Here</strong></a><strong> </strong><strong>to download our Order Form</strong></p> <hr> <p></p><img src="https://click.info.mailssenders.com/open.aspx?ffcb10-febf157873650374-fe1f16737d60027b711378-fe3311737164047c711374-ff2f17717d60-fe3910797364047d751770-ff931177&d=120002&bmt=0" width="1" height="1" alt=""></custom></td></tr></table><p style="text-align: center;">If you don't want to hear from us <a href="https://click.info.mailssenders.com/unsub_center.aspx?qs=e91042b99e10ad788038822910a76b41dcce32056e2dedaa8887ac0874b7cd7c5993bdeb443457ba9c9e4ee676369d774e1ffb20c478a64434298660047ee61040033500ae5f3051" >Unsubscribe</a></p> </td> </tr> </tbody> </table> </td> </tr> </tbody> </table> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table> </td> </tr> </table> </td> </tr> <tr> <td valign="top"> </td> </tr> </table> </body> </html> --B15WVlKuAboc=_?:--
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