Why you should attend: Software has become pervasive in medical product manufacturing documentation and cGMP compliance actions, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. Software is being developed for routing, managing, approving and signing all manner of cGMP documentation, maintenance of "controlled documents" as well as their update and archiving. The U.S. FDA has eliminated it's "selective enforcement" policy and is looking for proper implementation of the control of electronic records and electronic signatures, that can withstand legal review in a court of law. Companies may try to say they are using "hard copies" as their controlled documents, but this is increasingly becoming a wrong belief as employees use the electronic versions to make and implement cGMP decisions. Regulatory auditors are more comfortable with delving into software issues. Recent problems in unrelated industries show the dangers of neglecting thorough, and risk based Part 11 software verification and validation activities. Simple but effective and real world 21 CFR Part 11 software V&V is even more important in today’s resource constrained industrial environment.

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