Latest Master Validation Plan - The Unwritten Requirements
About This Event
Overview:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.
Why should you Attend:
Verification and validation requirements have always been part of the US FDA's GMPs.However, with increasing technology, both industry and regulatory agencies expectations have increased.
Areas Covered in the Session:
The 11 key documents for software validation
Incorporating 21 CFR Part 11 requirements
Suggested "test case" formats
Who Will Benefit:
Supplements
QA
RA
R&D
Engineering
Production
Operations
Speaker Profile:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
Event Fee: One Dial-in One Attendee Price: $290.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]