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TUESDAY JUNE-10-2014

01:00 PM | 02:30 PM - EDT - DURATION: 90 MINUTES

Live webinar on "DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions" DESCRIPTION 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 should you 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 CEmarking 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 Live One Dial In - One $189Attendee One Dial In Unlimited attendance (To be arranged in a $249Conference room/Meeting room. Note : Only One Dial In Allowed)

Combo Combo 1 (One Dial In - Unlimited $329attendance + On Demand Recorded Session) Combo 2 (One Dial In - Unlimited $349 attendance + Training CD)

R&D Engineering Production Operations Marketing 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

About Speaker

Recorded On Demand ( 90 Days of online $289Streaming access available after the live session ) Play Back Unlimited Views ( Recorded file $319 available for download after the live session ) Get Training CD $359

Multiple Location $109 Multiple location 9 - Up to 5 Dial in $499 allowed

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Dhf, dmr, dhr, technical file and design dossier key requirements and future directions