Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements by globalcompliancepane


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Design History Files (DHF), Device Master Records (DMR), Device
History Records (DHR), Technical Files , Design Dossiers - The

Date: Wednesday, March 6, 2013                                         Time: 10:00 AM PST | 01:00 PM EST

Course "Design History Files (DHF), Device Master
Records (DMR), Device History Records (DHR),                   Duration:       90 Minutes
Technical Files , Design Dossiers - The
                                                               Instructor:     John E Lincoln
Requirements" has been pre-approved by RAPS as
eligible for up to 1.5 credits towards a participant's         Location:       Online
RAC recertification upon full completion.

                     John E Lincoln
                     Consultant, Medical device                            Register Now
                     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. In
addition, he has successfully designed, written and run all types of process, equipment and software
qualifications/validations,   ...more

This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF per the
CGMPs, 21 CFR 820.30 (j) - 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";

Areas covered in the session:

    l   The EU's MDD and the Technical File / Design
    l   Device Classification - U.S. FDA vs. EU MDD
    l   Design Control 'Over Time' vs. a Product's 'Snapshot
        in Time' - Differing Philosophies
    l   DHF "Typical" Contents and Deliverables
    l   The DMR and DHR / Lot / Batch Record
    l   TF / DD Required Contents
    l   Parallel Approaches to Documentation - Teams
    l   FDA and NB Audit Focus

Who Will Benefit:

    l   Senior management in              Suggest a Topic
        Drugs, Devices, Biologics,
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        Dietary Supplements
    l   QA
    l   RA
    l   R&D
    l   Engineering                       Click here to
    l   Production
                                        register for this
    l   Operations
    l   Marketing                            webinar

It would be really nice if you can circulate this mail to all your deserving colleagues who can
immensely benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

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