Conference Description:

Overview:
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:
Engineering
Production
Operations
Senior Management in Drugs

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: US $290.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]