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Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements
Date :
Place : United States, Fremont
Contact Person:Event Manager
Description:
Overview It will also 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"; 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.Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements will be held in Fremont,United States on date 2019-01-09
Deadline for abstracts/proposals : 9th January 2019
Organized By :Traininng.com LLC
Keynote Speakers : 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. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, r
Conference Highlights :The EU's MDD and the Technical File / Design Dossier Device Classification - U.S. FDA vs. EU MDD Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies DHF "Typical" Contents and Deliverables The DMR and DHR / Lot / Batch Record TF / DD Required Contents Parallel Approaches to Documentation - Teams FDA and NB Audit Focus
Venue :Fremont, CA, USA
Check the event website for more details.
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