The FDA’s DHF, DMR and DHR Design Dossier for Documentation 2015
15 Sep 2015
Webinar
Description
Topics
Meeting the cGMP requirements
What is the DHF, DMR, and DHR
The Technical File / Design Dossier
The 9 key elements
Similarities / Differences in the two document systems
The 13 key elements
What is required to compile either / both
Suggested SOP contents for both documentation systems
Who should Attend
QA/RA Professionals
Senior management in primarily in Devices and Combination Products Professionals
Engineering Professionals
R&D Professionals
Manufacturing Professionals
Operations Professionals
Document Control Professionals
Past Events
The FDA’s DHF, DMR and DHR Design Dossier for Documentation 2015 - 15 Sep 2015, Webinar (53427)
Important
Please, check "The FDA’s DHF, DMR and DHR Design Dossier for Documentation" official website for possible changes, before making any traveling arrangements