2012 - DHF, DMR, DHR, and the Technical File-Design Dossier - Similarities and Differences - Webinar By GlobalCompliancePanel

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: One of our most popular webinars, updated with the latest FDA and EU 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 File 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/DD. And how / where do the DMR and DHR fit? 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
The DMR and DHR / Lot / Batch Record
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
QA
RA
R&D
Engineering
Production
Operations
Marketing
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
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