IQ, OQ, PQ in the Verification and Validation Process

This course will guide you on 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 product use hazard analysis per ISO 14971:2019 and ICH Q9.

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, with major problems in a validation's DQ, IQ, OQ, and PQs.  A Master Validation Plan is not specifically mentioned in the cGMP's.  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 1000's of dollars.  The FDA / ICH Q-series provide valuable insights for all regulated industries. 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.    

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 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, et al, software V&VT, 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 have been "field tested" with regulatory agencies in US, EU, and Asia.

Areas Covered in the Session : 

• The Master Validation Plan and it's 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 recently changed FDA's 10 key documents for software validation
• Incorporating 21 CFR Part 11 requirements
• Data Integrity and Cybersecurity
• Key "Working" Definitions

Who Should Attend:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their company’s planning and execution of verification and validation, based on a proper understanding of the roles of IQ, OQ, and PQ, or equivalent terminology. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

• Senior management
• Middle management
• Research & Development
• Engineering
• Software
• QA / RA
• Manufacturing
• Operators
• Consultants
• cGMP instructors
• All personnel involved in verification and/or validation planning, execution and documentation.

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100,worldwide.  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 and book chapters (including 5 chapters in 2 RAPS V&V textbooks)  in peer reviewed publications, conducted workshops and webinars worldwide.  John is a graduate of UCLA.