DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
Website https://compliance2go.com/product/?pid=CP2014-395 |
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 - CFPDESCRIPTIONThis 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 bothAreas Covered In the Session:The U.S. FDA's DHFThe EU's MDD and the Technical File / Design DossierDesign Control vs. a Product 'Snapshot in Time'DHF "Typical" ContentsTF / DD Expected ContentsParallel Approaches to Documentation -- TeamsFuture DirectionsFDA and NB Audit FocusWho will benefit:Senior management in Drugs, Devices, Biologics, Dietary Supplements QARAR&DEngineeringProductionOperationsMarketingWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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