FDA – Advanced Clinical Bioresearch Monitoring Course (BR301)

FDA Training Facility
Rockville, MD

The PSG partners will present the following subject as part of the FDA’s annual enforcement training for field inspectors: Auditing Electronic Systems: Independent Consultant Perspective.

The session objectives are as follows:

• Demonstrate what to look for regarding compliance with 21 CFR part 11
• Identify software development/acquisition models most frequently utilized in studies
• Identify what to look for in regards to SOPs, validation documentation, staff qualifications, and training