Overview
How to develop or improve upon a Master Verification and Validation Plan / System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 requirements; based on product use hazard analysis per ISO 14971:2019 and ICH Q9. Facilities, equipment, software, and the QMS must be addressed.
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. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. Risk Management, the QMS, cybersecurity and 21 CFR Part 11 must be considered.
Why Should You Attend
Verification and validation requirements for facilities, equipment, processes, QMS, hardware and software, have always been part of the US FDA’s GMPs. However, with increasing technology, both industry and regulatory agencies expectations have increased. Recent high-profile field problems indicate that V&V activities are not planned or carried out as completely as expected, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971 (ISO 14971 will have increased emphasis under the new FDA changes to the Device QSR / QMSR). Cybersecurity has become a major issue. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution.
Webinar Takeaway
- Verification or Validation -- Recent regulatory expectations
- The Master Validation Plan / structure
- Product Validation – how it differs from process / equipment V&V
- Process / Equipment / Facility Validation -- FDA's guidance
- "Requirements" - the Start of V&V
- When and How to use DQ, IQ, OQ, PQ, or their equivalents
- How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
- The 10 key documents for software validation; Cybersecurity
- Incorporating 21 CFR Part 11 requirements
- Suggested various “test case” formats
Who Will Benefit
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
-
Consultants; others tasked with product, process, software ... validation responsibilities
John E. Lincoln – Principal Consultant, J.E. Lincoln & Associates LLC
John E. Lincoln is the Principal of J.E. Lincoln & Associates LLC, bringing over 36 years of experience in FDA-regulated industries, including 22 years as an independent consultant. He has successfully partnered with organizations ranging from startups to Fortune 100 companies across the U.S., Mexico, Canada, France, Germany, Sweden, China, and Taiwan.
John specializes in Quality Management Systems (QMS), regulatory compliance, and FDA remediation strategies. His expertise spans 510(k) submissions, Design Control and Design History Files, ISO 14971 risk management, CAPA systems, process, product, and software validation, and technical documentation.
As a recognized industry expert, John helps medical device and life science companies ensure FDA, ISO, and global regulatory compliance through practical, risk-based quality and validation solutions.
