How to develop or improve upon a Master Verification and Validation Plan and System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements.
Why should you Attend:
The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution, documented in a corporate MVP and implemented by other V&V documents.
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:
Senior Management in Drugs
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: US $290.00
Compliance4All DBA NetZealous,