Webinar Includes : All the training handouts , certificate ,Q/A and 180 mins Live Webinar
Who will Benefit
- Senior Management
- Regulatory Affairs
- Quality Assurance
- R&D and Engineering
- 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, TD, and then document their decisions in harmony with regulations. The Shift from EU's MDD to the MDR.
- The U.S. FDA's DHF
- The EU's MDR and the Technical Documentation File
- Design Contol vs. a Product 'Snapshot in Time'
- DHF /D&DF Required Contents
- The Risk Management File (ISO 14971)
- The Use Engineering File (IEC 62366-1)
- TD Expected Contents
- Parallel Approaches to Documentation -- Teams
- The DMR and DHR
- Future Directions
- FDA and NB Audit Focus
What are U.S. FDA and EU MDR requirements for DHFs, DMRs, DHRs, and Technical Documents / Files? Formats, contents, and their commonalities, differences and interrelationships.
This webinar will examine the existing and proposed requiements for the FDA's DHF and the MDR's tD -- how to meet and document them. Their differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future convergences and trends. Typical DHF Table of Contents, including Risk Management and Use Engineering. Technical Documentation File 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 U.S. FDA and a Notified Body.
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). ISO 13485:2016 has identical requirements under Design and Development. In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical FiIe/Design Dossier and now Technical Documentation. Currently they serve differnt purposes, support different goals, but the TF/DD/TD now addresses components of the DHF. And the DHF has borrowed some features required in the TF/DD/TD. Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both. And what are DMRs and DHRs relationship to DHFs, TF/DDs?
Industries who can attend
This 180-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty John E Lincoln
Principal, J. E. Lincoln and Associates LLC. John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry 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 / CGMP audits and 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).