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

April 25, 2011 - PRLog -- Overview: 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
   QA
   RA
   R&D
   Engineering
   Production
   Operations
   Marketing


Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

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