Date : Wednesday, June 29, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 90 Minutes Price : $245.00
Live Webinar DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
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. 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
Click here to register for this webinar Who Will Benefit: l
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Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Marketing
Instructor Profile: John E Lincoln Consultant, Medical device and Regulatory Affairs 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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