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Latest Master Validation Plan – The Unwritten Requirements
June 18 @ 9:00 am - 12:00 pm CDT$290.00
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:
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
Event Fee: One Dial-in One Attendee Price: $290.00
Compliance4All DBA NetZealous,
Email: [email protected]