San Francisco Professional Events List


Latest Master Validation Plan - The Unwritten Requirements


Date
Jun 18, 2019 - 09:00 AM
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
161 Mission Falls Lane, Suite 216,,

Fremont,
California,
USA,
ZIP: 94539
Phone: 8004479407

Overview:
FDA Warning Letters and recent high-profile recalls indicate major
cGMP deficiencies in many companies. One major failing is lack of
sufficient or targeted risk-based company-wide V&V planning.

Why should you Attend:
Verification and validation requirements have always been part of
the US FDA's GMPs.However, with increasing technology, both
industry and regulatory agencies expectations have increased.

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:
Supplements
QA
RA
R&D
Engineering
Production
Operations

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: $290.00

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

Event Categories
Keywords: Educational, Health




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