The DHF, DMR, DHR, and Technical Documents File
09-January-2025 :01:00 PM EST Duration : 90 Minutes
John E. Lincoln,
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assuranc Read more
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union 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 7.3 requires the same. In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical Document FiIe. Currently they serve differnt purposes, support different goals, but the TD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TD. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.
Course Objectives:
This webinar will examine the existing and proposed requiements for the U.S. FDA's Design History File (DHF) and ISO 13485 7.3's Design and Development File; both proof of compliace to the regulations. Also discussed are their derivitive documents, the DMR and DHR. It will consider the European Union's MDR Technical Documentation 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; Similiarities and differences; Future trends; Typical DHF Table of Contents; Technical Documentation and General Safety and Performance (old Essential Requirement) Table of Contents; The importance and usefulness of the "GS&P" Section and a suggested Matrix; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.
Course Outline:
• The EU's MDR and the Technical Documents File
• Device Classification -- U.S. FDA vs. EU MDD
• Design Contol vs. a Product 'Snapshot in Time'
• DHF "Typical" Contents
• The DMR and DHR / Lot / Batch Record
• Technical File's Expected Contents
• Parallel Approaches to Documentation -- Teams
• FDA and NB Audit Focus
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Senior management in Drugs, Devices, Biologics, Dietary Supplements
• QA
• RA
• R&D
• Engineering
• Production
• Operations
• Marketing
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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