Date :
Place : United States, Fremont
Contact Person:Event Manager
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]Deadline for abstracts/proposals : 27th January 2019
Organized By :Netzealous LLC DBA - Compliance4All
Keynote Speakers :
Venue :Fremont, CA, USA
Check the event website for more details.