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

Important

Please, check "The FDA’s DHF, DMR and DHR Design Dossier for Documentation" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device

Other Events with Similar Categories

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions