GotoWebinar: CGMP’s DHF, DMR, DHR, and EU’s Technical Documentation – May 17, 2022, 1 PM EDT – Lincoln

GotoWebinar: CGMP’s DHF, DMR, DHR, and EU’s Technical Documentation – May 17, 2022, 1 PM EDT – Lincoln

March 20th, 2022 // 8:42 pm @

One of our most popular webinars, updated with the latest FDA and EU requirements. As U.S. companies go global, they must meet different product design documentation.  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 FiIe or Design Dossier, now Technical Documentation.  Currently they serve different purposes, support different goals, but the TF/DD/TD is moving in the direction of the DHF.  And how / where do the DMR and DHR fit?   Being aware of the similarities and differences can further concurrent development and/or updates to both.

This webinar will examine the existing and proposed requirements for the FDA’s DHF — including its derivative documents, the DMR and DHR.  It will consider the existing EU MDD’s TF/DD and new MDR Technical Documentation, requirements, and evaluate the documents’ differing purposes / goals. 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, Design Dossier, Technical Documentation Table of Contents;  The importance and usefulness of the “Essential Requirements” / “General Safety and Performance Requirements”;  Structure of the “Declaration of Conformity”; Notified-Body reviews;  Parallel approaches to development. Finally, the differing approaches to file audits and 483s by the FDA and the EU Notified Body will be discussed.

Who Will Benefit:

  • QA
  • Senior management in drugs, devices, biologics and dietary supplements
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Marketing

About the Speaker

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years experience in U.S. FDA-regulated industries, 23 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.  He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.  He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).  In addition, John has prior experience in military, government, electronics, and aerospace.  He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology.  John is a graduate of UCLA.

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