DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
Course "DHF, DMR, DHR, Technical File and Design Dossier Key Requirements and Future Directions" has been pre-
approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
Date & Time:
Wednesday, May 23, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Price : $245.00
John E Lincoln Consultant, Medical device and Regulatory affairs,
(for one participant)
Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/DD 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 File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
Why you should attend: Increasingly U.S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/B9DD. Being aware of the similarities and differences can further concurrent development and/or updates to both.
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peerreviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDAregulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. ...more
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Areas Covered in the Session: l l l l l l l l
The U.S. FDA's DHF The EU's MDD and the Technical File / Design Dossier Design Control vs. a Product 'Snapshot in Time' DHF "Typical" Contents TF / DD Expected Contents Parallel Approaches to Documentation -- Teams Future Directions FDA and NB Audit Focus
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Senior management in Drugs, Devices, Biologics, Dietary
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R&D Engineering Production Operations Marketing
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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Published on Apr 10, 2012
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It...