- TypeConference
- Location Fremont, California, United States
- Date 29-01-2019
Education/Teaching/Training/Development
Advertising/Marketing
Manufacturing
Medical/Healthcare/Hospital
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]
Netzealous LLC DBA - Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: +1-800-447-9407 Email: [email protected]
+1-800-447-9407