RAPS Approved Webinar on
The DHF, DMR, DHR, and the Technical File-Design Dossier - USFDA and EU MDD Requirements Date: Wednesday, November 14, 2012 Course "The DHF, DMR, DHR, and the Technical FileDesign Dossier - USFDA and EU MDD Requirements" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
Time: 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Instructor: John E Lincoln Location: Online Price : $245.00 (for one participant)
John E Lincoln Consultant, Medical device and Regulatory affairs,
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. ...more
Overview: This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. 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"; selfdeclaring 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.
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The U.S. FDA's DHF The EU's MDD and the Technical File / Design Dossier Device Classification -- U.S. FDA vs. EU MDD 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 FDA and NB Audit Focus
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Senior Management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Marketing
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Published on Oct 4, 2012
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR and DH...