Verification and validation requirements have always been part of the US FDA’s GMPs. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system validations.
Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis/risk management allows the 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. The mandatory, but frequently neglected, 11 documents that must be included in a software V&V. The QMS and 21 CFR Part 11 must be considered.
The FDA/ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by the 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.
Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis/risk management allows the 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. The mandatory, but frequently neglected, 11 documents that must be included in a software V&V. The QMS and 21 CFR Part 11 must be considered.
Why you should Attend:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is the lack of sufficient or targeted risk-based company-wide V&V planning. 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.The FDA/ICH Q-series provide valuable insights for all regulated industries, not just pharma. The billions of dollars spent by the 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.
Areas Covered in the Session:
- The Master Validation Plan and its Structure
- Hardware/Equipment and Software Validations
- Test Cases and Test Report Formats
- When and How to use DQ, IQ, OQ, PQ, or their equivalents
- Product Risk Management (per ISO 14971:2019 and ICH Q9)
- Product/ Process/Equipment/Facility Verification/Validation
- The 11 key documents for software validation
- Incorporating 21 CFR Part 11 requirements
- Data Integrity and Cybersecurity
- Key 'Working' Definitions
Speaker
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
Who Should Attend
- Senior management in Drugs, Devices, Biologics, Dietary Supplements
- Marketing
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants; others tasked with the product, process, and software validation responsibilities
