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Boston Professional Events List


Live Webinar DHF, DMR, DHR, and Technical File / Design Dossier – And the New EU MDR”


Date
Oct 19, 2021 - 01:00 PM
Organizer
wcswebinar
Venue
Onlinewebinar
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

Live Webinar DHF, DMR, DHR, and Technical File / Design Dossier – And the New EU MDR”


October 17, 2020 01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes
 

Description

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. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; 

 

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

 

Who will Benefit

• Corporate Management
• QA
• RA
• R&D
• Engineering
• Production
• Marketing



Speaker Details


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.


Event Categories
Keywords: Education




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