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. Developing the Plan. 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). How Product Risk Management under ISO 14971 fits into V&V decisions. A matrix simplifies “as-product”, “in-product”, process, and equipment, et al, software V&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 must also be considered. This webinar separates fact from Internet fiction on this subject.
Why Should You Attend?
Verification and validation requirements have always been part of the US FDA’s GMPs. They are a requirement of ISO 13485, as well as both the EU’s MDD and new MDR. 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, are not documented in a top tier Master Validation Plan. Validations may not be fully utilizing the power of current risk management tools, as identified in ISO 14971, or meeting the requirements of IEC 62366-1, -2, usability engineering / human Factors. The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. Same for FDA’s Process Validation Guidance document.
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, documented in a corporate MVP and implemented by other V&V documents.
- Verification or Validation - Recent regulatory expectations
- Working Definitions
- The Master Validation Plan and its structure
- Product Validation - how it differs from process / equipment V&V
- Process / Equipment / Facility Validation - including FDA's recent guidance
- 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 11 key documents for software validation
- Developing and incorporating 21 CFR Part 11 requirements
- Suggested “test case” formats
John E. Lincoln,
J. E. Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.
- Corporate Management
- Personnel in FDA- and EU MDD / MDR-regulated industries, Devices, Combination Products