Master Validation Plan for FDA CGMP Compliance
Recorded Webinar | John E. Lincoln | From: Mar 25, 2026 - To: Dec 31, 2026
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Verification and validation requirements have always been part of the US FDA’s GMPs. Yet companies still struggle with the performance and documentation of Equipment, Process, Software, and quality management system DQ, IQ, OQ, and PQs in their validations. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 / ICH Q9 hazard analysis / risk management allows development of meaningful product validations. The roles of different V&V protocols examples are provided and discussed. 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, software V&V, assuring key FDA requirements are not overlooked. Sample IQ, OQ, and PQs are illustrated and discussed.
The mandatory, but frequently neglected, recently updated FDA Guidance on 10 documents that must be included in a software V&V will be presented as a model. The QMS, cybersecurity and 21 CFR Part 11 must be considered, and recommendations presented as to where to locate their V&V in a validation test report. All points in this webinar have been field tested with regulatory agencies in US, EU, and Asia.
Areas Covered:-
Background:-
How to develop or improve upon DQ, IQ, OQ and PQs and the Master Verification and Validation Plan / System that meets risk/U.S. FDA CGMP, ICH Q-series, and ISO 13485 requirements; based on patient / user risk per ISO 14971:2019 and ICH Q9.
Why Should You Attend?
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/execution, with major problems in a validation's DQ, IQ, OQ, and PQs. A Master Validation Plan is not specifically mentioned in the CGMPs. However, one is expected by the US FDA, under the "c" in CGMP. And, with increasing technology, both industry and regulatory agencies expectations have increased. Recent field problems indicate that V&V activities are not planned or carried out as completely as expected, don't fully utilize the power of current risk management tools, as identified in ISO 14971, and waste thousands of dollars. The FDA / ICH Q-series provide valuable insights for the regulated pharma industry.
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, especially with the DQ, IQ, OQ, and PQs.
Who Will Benefit?
