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Risk Based Verification 2020 - Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements
Topics/Call fo Papers
Webinar 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.
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.
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,
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.
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,
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Last modified: 2020-10-26 23:02:34