The DHF, DMR, DHR, and the Technical File / Design Dossier Regulatory Requirements
Date & Time: Wednesday, November 2, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Price : $245.00
(for one participant)
John E Lincoln Consultant, Medical device and Regulatory affairs,
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.
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 different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF).
Areas Covered in the Session:
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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
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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