Compiling the Design History File, and Technical File, Design Dossier

John E Lincoln
John E Lincoln
60 Minutes
Product Id:
6 months

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Price Details
$189 Recorded
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This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.

Major modules of a DHF SOP and a TF / DD SOP will be presented and discussed - the webinar will address the development of a new, or revision of an existing DHF SOP and TF / DD to ensure they meet regulatory expectations and assist those charged with compiling, updating and/or revising these mandatory documents.C15

Why should you attend: The U.S. FDA implemented Design Control requirements in 1996/97, and yet continues to find problems in the key design control document, the Design History File (DHF). Yet this drives the Device Master Record as well as providing major support for the EU MDD's Technical File / Design Dossier. What are the FDA expectations for the DHF under Design Control? What are the EU MDD / Notified Body's expectations for the complementary TF / DD? How are they similar? What are the important differences? In what ways are they moving together under Harmonization? Evaluate some of the key inputs to both, which should form the basis for SOP's explaining the development of each.

Areas Covered in the Session:

  • Design Control and the DHF
  • The 9 Key Elements in the DHF
  • The DHF/DMR and the MDD's TF / DD
  • The 13 Key Elements of the TF / DD
  • Differences and Similarities
  • High Risk Areas
  • Movements Toward Harmonization
  • Incorporating These Points Into a Design Control / DHF SOP and a TF / DD SOP

Who Will Benefit:
  • Senior management primarily in Devices; some value to Drugs, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations

Speaker Profile
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, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

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