A Simpler Approach to Implementing , Electronic Records, Signatures - Webinar By GlobalCompliancePanel

(bit.ly)

Areas Covered in the Session:
Verification or Validation
Current Regulatory Expectations and Recent Audit "Hot Buttons"
The Part 11 Project Validation Plan
The Simplified Approach to 21 CFR Part 11 Compliance and Software V&V
When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
Simplified Sample V&V Test Cases and their Development
The FDA's 11 Key V&V Documentation Elements
GAMP / Other Considerations
Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants