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    Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

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    Website https://www.complianceonline.com/design-history-files-device-master-records-device-history-records-w | Edit Freely

    Category

    Deadline: April 24, 2021 | Date: May 04, 2021

    Venue/Country: online event, U.S.A

    Updated: 2021-04-21 00:35:21 (GMT+9)

    Call For Papers - CFP

    Global companies must meet different product design documentation for the U.S. and the European Union / Common Market. 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 File 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 may soon borrow some features required in the TF/DD. Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both. What are DMRs and DHRs relationship to DHFs, TF/DDs?

    This webinar will examine the existing and proposed requirements for the FDA's DHF and the MDD's TF/DD -- how to meet and document them. Their differing purposes / goals, required and desirable contents and areas requiring frequent re-evaluation / update will be discussed. Similarities and differences, and future convergences and trends will be examined. Typical DHF Table of Contents, Technical File or Design Dossier Table of Contents will be presented.

    The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. We will also discuss parallel approaches to development, the Device Master Record / Device History Record "tie in" and differing approaches to file audits by the U.S. FDA and a Notified Body.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.