Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

Why Should You Attend:

Global companies must meet different product design documentation for the U.S. and the European Union / Common Market. 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 File or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF may soon borrow some features required in the TF/DD. Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both. What are DMRs and DHRs relationship to DHFs, TF/DDs?

This webinar will examine the existing and proposed requirements for the FDA's DHF and the MDD's TF/DD -- how to meet and document them. Their differing purposes / goals, required and desirable contents and areas requiring frequent re-evaluation / update will be discussed. Similarities and differences, and future convergences and trends will be examined. Typical DHF Table of Contents, Technical File or Design Dossier Table of Contents will be presented.

The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. We will also discuss parallel approaches to development, the Device Master Record / Device History Record "tie in" and differing approaches to file audits by the U.S. FDA and a Notified Body.

Areas Covered in the Webinar:

• The U.S. FDA's DHF
• The EU's MDD and the Technical File / Design Dossier
• Design Control 'Over Time' vs. a Product 'Snapshot in Time'
• DHF "Typical" Contents
• TF / DD Expected Contents
• Parallel Approaches to Documentation -- Teams
• The DMR and DHR -- DHF "Deliverables"
• Some Future Trends to Consider
• FDA and NB Audit Focus

Who Will Benefit:

All personnel involved in the U.S. FDA-regulated and CE-marking environments. Especially those involved in new medical device / combination product development, line extensions, and incremental product improvements; having to evaluate those changes in light of the DHF, TF/DD, and then document their decisions in harmony with regulations.

• Senior management
• Regulatory affairs
• Quality Assurance
• Production
• Engineering & R&D

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln 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, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published 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. Mr. Lincoln is a graduate of UCLA.

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