Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
Instructor : John E. Lincoln
Mar 04, 2020 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes
FDA Warning Letters and 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 term "risk-based really means. Aa review of Internet forums shows confusion as to what is risk and what is V&V planning. What is the VMP and the individual V&V plan and there formats and roles. What are the "must have" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated? Mandatory risk for Software / firmware V&V.
This webinar will review company's Validation Master Plan for major cGMP deficiencies. Review hazard and risk management tools per ISO 14971 and ICH Q9. Utilize sufficient or targeted risk-based V&V planning. Use the VMP and Product 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. The models presented simplify "as-product", in-product", process and equipment, software VT&V, assuring key FDA requirements are not overlooked. V&V of a company's QMS and 21 CFR Part 11 are considered.
In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.
Areas Covered in the Webinar:
- Verification or Validation -- Current regulatory expectations.
- Purpose, format, contents and execution of the Validation Master Plan and the Individual V&V Plans.
- When / how to use the DQ, IQ, OQ, PQ, or their ASTM E2500 equivalents.
- What is "risk-based"?
- Using the Risk Management tools of ISO 14971 and ICH Q9.
- The 11 Elements of the FDA’s software / firmware VT&V "Model".
- Part 11 and QMS software V&V.
- Key recent compliance problems and their resolution.
Who Will Benefit:
- Senior and middle management.
- Quality Assurance
- Regulatory Affairs
- Engineering, including software
- Sales and Marketing
- Operations / Production