The FDA's Design History Files, Device Master Records, Device History Record, and the EU's MDD TF/DD -- Documentation to meet their different purposes and device classifications. This webinar will examine the existing and proposed requirements for the U.S. FDA's Design History File (DHF) per the CGMPs, 21 CFR 820.30 (j) -- including its derivitive documents, the DMR (Device Master Record) and DHR (Device History / Lot Record). It will consider the European Union's MDD Technical File /Design Dossier requirements (similarities / differences), and evaluate the documents' differing purposes / goals, as well as the two (FDA’s and EU’s) different device classification schemes.
Why Should You Attend
One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation. The Device (21 CFR 820) and Combination Products (21 CFR 4) 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 FiIe 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 is adapting to some of the features of the TF/DD. 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.
Areas Covered in this Webinar
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF per the CGMPs, 21 CFR 820.30 (j) -- including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD 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. It will address typical DHF Table of Contents addressing the 9 must-have requirements of the cGMP guidelines; as well as the resulting DMR and DHR.
Then it will consider: Technical File or Design Dossier -- Table of Contents; The 13 key requirements; The importance and usefulness of the "Essential Requirements"; 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.
• What is the DHF, DMR, and DHR.
• Meeting the cGMP requirements.
• The 9 key elements.
• The Technical File / Design Dossier.
• The 13 key elements.
• Similarities / Differences in the two document systems.
• Suggested SOP contents for both documentation systems.
• Understand what is required to compile either / both.
Who Will Benefit
• Senior management in primarily in Devices and Combination Products Professionals
• QA/RA Professionals
• R&D Professionals
• Engineering Professionals
• Operations Professionals
• Manufacturing Professionals
• Document Control Professionals
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 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. 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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.View all trainings by this speaker