DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
Website https://worldcomplianceseminars.com/upcoming_webinar |
Edit Freely
Category Imports, exports, business, Accounts, law
Deadline: February 18, 2020 | Date: February 18, 2020
Venue/Country: U.S.A
Updated: 2020-01-04 18:35:38 (GMT+9)
Call For Papers - CFP
This webinar will examine the requiements for the FDA's DHF and the current and new requirements of MDD/MDR's TF/DD/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 trendsSession Highlights:• The EU's MDD and the Technical File / Design Dossier• Device Classification - U.S. FDA vs. EU MDD• Design Control 'Over Time' vs. a Product's 'Snapshot in Time' – Differing Philosophies• DHF "Typical" Contents and Deliverables• The DMR and DHR / Lot / Batch Record• TF / DD Required Contents• Parallel Approaches to Documentation – Teams• FDA and NB Audit FocusFaculty: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 TaiwanKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.