FDA – Advanced Clinical Bioresearch Monitoring Course (BR301)
FDA Training Facility
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