Latest Master Validation Plan - The Unwritten Requirements
Added by Compliance4all on 2019-04-17
Conference Dates:
Start Date: 2019-06-18Last Day: 2019-06-18
Conference Contact Info:
Contact Person: Event ManagerEmail: [email protected]
Address: 161 Mission Falls Lane, Suite 216,, Fremont, California, 94539, United States
Tel: 18004479407
Fax: 302-288-6884
Conference Description:
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]