Requirements for the U.S. FDA's DHF per the CGMPs, 21 CFR 820.30 and the almost now identical ISO 13485:2016 Design and Development File - including its derivitive documents, the DMR and DHR.
This webinar will examine the requirements for the U.S. FDA's DHF per the CGMPs, 21 CFR 820.30 and the almost now identical ISO 13485:2016 Design and Development File - including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, the new EU 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; 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" or “General Safety and Performance Requirements”; Structure of the "Declaration of Conformity"; self-declaring (being eliminated) 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.
Why You Should Attend
A popular webinar, 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 requires the Design and Development File. In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier, which will now have a new title. These classes of document serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. And what are the changes as the EU MDD now becomes the EU MDR? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.
Free documents/Article/ebooks/sops/checklist for Attendees.
- The U.S. FDA's DHF and ISO’s D&DF
- The EU's old MDD and the Technical File/Design Dossier
- The EU’s new MDR and the Technical Documentation
- Design Control 'Over Time' vs. a Product's 'Snapshot in Time' Technical Documentation
- DHF/D&DF "Typical" Contents and Deliverables
- The DMR and DHR/Lot/Batch Record
- TF/DD/TD Required Contents
- Parallel Approaches to Documentation - Teams
- FDA and NB Audit Focus
John E. Lincoln,
J. E. Lincoln and Associates
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 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 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. John is a graduate of UCLA.
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology, and Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.
- Corporate Management
- Personnel in FDA- and EU MDD/MDR-regulated industries, Devices, Combination Products