3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements

In this 3-Hour Virtual Seminar speaker will discuss differing approaches to file audits by the FDA and the Notified Body, Also the FDA's DHF, DMR, DHR, and the EU's MDD TF/DD Documentation to meet their different purposes and future directions, includes latest requirements of the ISO 13485:2016 QMS and the new EU MDR (Medical Device Regulation) and transitioning.

John E Lincoln
John E Lincoln
3 Hours
Product Id:
6 months

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Price Details
$340 Recorded
$540 Corporate Recorded
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This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF including its derivative documents, the DMR and DHR.

It will consider the European Union's MDD TF/DD requirements currently being phased out and the new MDR Technical Documentation being phased in.

It will 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 / Documentation Table of Contents; The importance and usefulness of the old "Essential Requirements" and new "General Safety and Performance 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.

Why should you 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 FiIe or Design Dossier under the old MDD, and the Technical Documentation requirements of the new MDR.

Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. 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 U.S. FDA's DHF
  • The EU's MDD and the Technical File / Design Dossier
  • The new MDR's Technical Documentation
  • MDD's "Essential Requirements" and MDR's "General
  • Safety and Performance Requirements"
  • Device Classification U.S. FDA vs. EU MDD
  • Design Contol vs. a Product 'Snapshot in Time'
  • DHF "Typical" Contents
  • The DMR and DHR / Lot / Batch Record
  • TF / DD / TD Expected Contents
  • Parallel Approaches to Documentation Teams
  • FDA and NB Audit Focus

Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics,Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing

Speaker Profile
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.

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