Design History Files, Device Master Records, Device History Records, and Technical Files

Design History Files, Device Master Records, Device History Records

, and Technical Files

Why Should You Attend:

Increasingly U.S. companies are going global and 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 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 and/or updates to both. And 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. Their differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similarities and differences, and future convergences and trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. Parallel approaches to development. The Device Master Record / Device History Record "tie in". Differing approaches to file audits by the FDA and the Notified Body.

Areas Covered in the Seminar:

The U.S. FDA's DHF.

The EU's MDD and the Technical File / Design Dossier.

Design Control vs. a Product 'Snapshot in Time'.

DHF "Typical" Contents.

TF / DD Expected Contents.

Parallel Approaches to Documentation -- Teams.

The DMR and DHR.

Future Directions.

FDA and NB Audit Focus.

Who Will Benefit:

Senior management

Regulatory affairs

Quality Assurance

Production

Engineering & R&D

All personnel involved in a U.S. FDA-regulated environment 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.

Instructor Profile:

John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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 so+E6ftware 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).

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