Planning to Meed 2020 - Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements Training

Risk Management Files to develop meaningful product and process validations. Address "worst case allowables". Also the role of the individual V&V plan, and different protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents, against a background of limited company resources.
FDA Warning Letters and high-profile recalls indicate major cGMP deficiencies in device and pharma companies on both sides of the Atlantic. One major failing is lack of sufficient or targeted risk-based V&V planning. And confusion over what the terms "risk-based", V & V,and other terms really mean.
Verification or Validation -- Current regulatory expectations.
The Master Validation Plan and the Individual V&V Plan.
Product V&V versus Process / Equipment V&V versus QMS V&V
When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
Speaker:
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant.