Overview:
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes/goals, as well as the two different device classification schemes. 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.
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes/goals, as well as the two different device classification schemes. 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.
Speaker
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 peer-reviewed 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 FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
Who Should Attend
- Senior Management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Marketing
