Boston Professional Events List


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


Date
Oct 17, 2017 - 07:00 PM
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 13485:2016 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




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