Production & Process Validation (Merging 820.75 with ISO 13485, and EU Annex 15)

Risk management is repeatedly cited as a core failure in FDA 483s and Warning Letters, driven by weak, non-targeted validation planning. Under the new QMSR, ISO 13485 places explicit emphasis on integrating ISO 14971 risk throughout the QMS. Despite billions spent annually, validation efforts often fail to deliver safety or efficacy. This course shows how proper, risk-driven upfront planning fixes that.

Merging the old 21 CFR 820.75 with the new QMSR / ISO13485 and EU Annex 15. How to develop or improve upon 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. Also meet the EU requirements and Asia's for product and process V&V. Risk management has always been neglected by many companies, per FDA 483s and Warning Letters issued.  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. The US FDA's change to ISO 13485 emphasis in the new device QMSRs changes the emphasis to more obvious requirements for consideration of ISO 14971 Risk throughout the company's QMS!

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 1000's of dollars.  The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised.  The fixes are not rocket-science, but require proper up-front V&V planning and execution through a company's QMR and product line.    

Verification and validation requirements have always been part of the US FDA’s GMPs.  They will receive more emphasis under the new QMSR. Yet companies still struggle with the performance of and documentation of Equipment, Process, Software, and quality management system,  DQ, IQ, OQ, and PQs, et al, in their validations.  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 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 MVP entries, IQ, OQ, and PQs. et al, 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" over decades with regulatory agencies in US, EU, and Asia.  

AGENDA

WHO SHOULD ATTEND:

• Senior Management
• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Consultant, and All personnel tasked with product, process, software, and validation responsibilities

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 42 years experience in U.S. FDA-regulated industries, 28 of which as head of his own consulting company. 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 FDA-compliant new product development and to market issues, quality assurance, regulatory affairs, QMS problem remediation and FDA responses, 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 VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles and book chapters in peer reviewed publications (5 chapters in RAPS textbook on V&V) conducted workshops and webinars worldwide on virtually all cGMP issues. John is a graduate of UCLA.