PUBLISH YOUR EVENTS!
Boston Professional Events List
Please wait...
Live Webinar DHF, DMR, DHR, and Technical File / Design Dossier – And the New EU MDR
Date
Oct 19, 2021 - 07:00 PM
Link to Website
Organizer
wcsseminars
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,
Hollywood,
FLORIDA,
United States,
ZIP: 33021
Phone: 347 282-5400
Ticket Price: $179 One Dial-in One Attendee, $395 Group, $249 Recorded, $295 CD/DVD
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 13485:2020 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.
Areas Covered
• 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
Who will Benefit
• Corporate Management
• QA
• RA
• R&D
• Engineering
• Production
• Marketing
Speaker Details
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.
Event Categories
Keywords: Education