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.
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
