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Tuesday, January 29, 2019
9:00 AM - 12:00 PM
9:00 AM - 12:00 PM See all dates and Times
https://www.compliance4all.com/control/w_product/~product_id=502268LIVE?channel=upcomingevents_Jan_2019_SEO
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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]
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]