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Validity : 29th Nov'24 to 09th Dec'24
The DHF, DMR, DHR, and the Technical Documentation File
- The U.S. FDA's 510(k) and DHF
- The EU's MDR and the Technical Documentation File (the EU's "Marketing Submission")
- Design Contol vs. a Product's 'Snapshot in Time' (Marketing Submissions)
- 510(k) and DHF "Typical" Contents
- The DMR and DHR / Lot / Batch Record - US and EU
- Technical File Expected Contents
- Focus on the General Safety and Performance Requirements and Why
- Parallel Approaches to Documentation -- Teams
- FDA Inspection and Notified Body Audit Focus
Overview of the webinar
This webinar will examine the existing requiements for the US FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF. It will consider the EU's recently revised MDR and it's Technical Documentation File requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similiarities and differences; Future trends; Typical DHF Table of Contents; Technical Document File Table of Contents; The importance and usefulness of the old "Essential Requirements", now "Genneral Safety and Performance Requirements" and a suggested matrix format; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file inspections / audits by the FDA and Notified Bodies will be discussed.
Who should attend?
- Senior management in Devices, and Combination Products
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Marketing
Why should you attend?
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). ISO 13485 mandates the same, a Design and Development File, per 7.3, which is now to be part of the EU's MDR-required documentation. In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical Documentation FiIe. Currently they serve differnt purposes, support different goals, but their roles do overlap. 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, especially for those companies marketing (or plan to) in both sides of the Atlantic.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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, CAPA systems and analysis. 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.