Risk Based 2021 - Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements

Join this course online for a discussion of the webinar how to review a company's Validation Master Plan for major cGMP deficiencies. Review hazard and risk management tools per ISO 14971 and ICH Q9. Major industry failings are lack of sufficient or targeted risk-based V&V planning.
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.
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
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.