One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. 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 FiIe or Design Dossier under the old MDD, and the Technical Documentation requirements of the new MDR. Currently they serve differnt purposes, support different goals, but the TD File is moving in the direction of the DHF.
And the DHF is adapting to some of the features of the TDFile. 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.
Why you should attend
This webinar will examine the existing and proposed requiements for the U.S. FDA's DHF - including its derivitive documents, the DMR and DHR. It will consider the European Union's new MDR Technical Documentation requirements, which replace the old Technical File / Design Dossier. It will evaluate the documents' differing purposes / goals, as well as the two different device classification schemes, and CE-marking requirements. Required and desirable contents will be discussed.
Also considered: Areas requiring frequent re-evaluation / update; Similiarities and differences; Future trends; Typical DHF Table of Contents; Technical Documentation Table of Contents; The importance and usefulness of the new "General Safety and Performance Requirements" (replacing the old "Essential Requirements"); Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed and changes; parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
Who Will Benefit
- Senior management primarily in Devices, Combination Products
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Marketing
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.
Time: 08:00 AM PDT | 11:00 AM EDT
Session 1
- Introduction
- Design Control Under 21 CFR 820.30
- Design and Development Planning under ISO 13485:2016 7.3
- The U.S. FDA's DHF
- The EU MDR's D&DPF
- MDR's "General Safety and Performance Requirements"
- Device Classification - U.S. FDA vs. EU MDD
- Device Classification - U.S. FDA vs. EU MDD
- Design Files' "Typical" Contents
- The DMR and DHR / Lot / Batch Record
- TD Expected Contents
Session 2- Risk Management / File Under ISO 14971
- Narrative
- Hazzard Analysis
- FTA
- D-, P-, and U-FMECA's
- Report
Session 3- Human Factors / Use Engineering Under IEC 62366-1:2015
- The User Interface
- The 9 Stages
- The HF / UE File
Session 4- Putting It All Together
- Design Control
- The Team
- Concurrent Compilation of the Three Files
- Derivitive Documents Development
- Completion
- FDA and NB Audit Focus
- Final Q & A
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