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DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions

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Category Biotechnology , Food Safety Compliance , Medical Device , Pharmaceutical

Deadline: January 15, 2021 | Date: January 15, 2021

Venue/Country: Houston, U.S.A

Updated: 2014-12-09 19:10:48 (GMT+9)

Call For Papers - CFP


This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals.

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.

Why you should attend:

Increasingly U.S. companies are going global and 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. 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/B9DD. Being aware of the similarities and differences 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

Design Control vs. a Product 'Snapshot in Time'

DHF "Typical" Contents

TF / DD Expected Contents

Parallel Approaches to Documentation -- Teams

Future Directions

FDA and NB Audit Focus

Who will benefit:

Senior management in Drugs, Devices, Biologics, Dietary Supplements








Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of Attendance

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.