It will also consider the European Union's MDR Technical Documentation 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 documentation File Table of Contents; The importance and usefulness of the `General Safety and Performance Requirements` (the old `Essential Requirements`); Structure of the `Declaration of Conformity`; self-declaring changes and/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.
Also considered: Areas requiring frequent re-evaluation/update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical documentation File Table of Contents; The importance and usefulness of the `General Safety and Performance Requirements` (the old `Essential Requirements`); Structure of the `Declaration of Conformity`; self-declaring changes and/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:
One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union 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). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical Documentation (TD). Currently, they serve different purposes and support different goals, but the TD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TD, while each serves differing goals. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.Areas Covered in the Session:
- The EU's MDR and the Technical File / Design Dossier
- Device Classification - U.S. FDA vs. EU MDR
- Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies
- DHF `Typical` Contents and Deliverables
- The DMR and DHR / Lot / Batch Record
- TF / DD Required Contents
- Parallel Approaches to Documentation - Teams
- FDA and NB Audit Focus
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
