The FDA’s DHF, DMR and DHR Design Dossier for Documentation 2015

The FDA s DHF, DMR and DHR Design Dossier for Documentation 2015 is a webinar that covers topics such as:

• 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

The FDA s DHF, DMR and DHR Design Dossier for Documentation 2015 is intended for:

• 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