Master Validation Planning To Meet U.S. FDA cGMP ISO 13485 and ICH Q9 / ISO 14971 Requirements

The “Master Validation Planning To Meet U.S. FDA cGMP, ISO 13485 and ICH Q9 / ISO 14971 Requirement” webinar will address the need for a company to compile and maintain a Validation Master Plan.  The VMP / MVP lists all the validatable entities in a regulated company, facilities, clean rooms, production and test equipment, processes, products.  It describes what the company requires of each category in terms of validation, verification, preventive maintenance, calibration, re-V&V, et al.  The webinar will discuss working V&V definitions, the supporting documentation addressed by such a plan, including the structure of V&V Test Reports, IQ, OQ and PQ Test Cases.  And how to incorporate patient risk (ISO 14971, ICH Q9) into such V&V planning.

• Understand published V&V terms definitions and suggested “working definitions”
• Know the key elements of any VPM
• Define the key sections of an individual V&V Test Report / Plan
• “Requirements” and the IQ, OQ, and PQs
• Test Cases and Sampling
• Incorporating “Risk” for “risk-based” V&V
• The strategic overview 

• Validation Planning elements
• The Validation Master Plan 
• Patient / User Risk per ISO 14971 / ICH Q9 hazard analysis / risk management  
• The individual V&V Plan / protocols  
• Equipment and process Requirements / DQs, IQs, OQs, and PQs (or equivalents per ASTM E2500)  
• Software / Firmware “as-product”, “in-product”, process, and equipment, V&V “model”  
• The QMS V&V and 21 CFR Part 11, Electronic Records / Signatures.

Verification and validation requirements have always been part of the US FDA’s GMPs.  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, and may not be fully utilizing the power of current risk management tools, as identified in ISO 14971.  The FDA / ICH Q-series, including Q9, provide valuable insights for all regulated industries, not just pharma. 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.  

• Senior management
• Middle management / operations
• Production / manufacturing
• R&D
• Engineering
• QA / RA
• Marketing 

John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years experience in U.S. FDA-regulated industries, 23 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 in peer-reviewed journals, conducted workshops and webinars worldwide and is also a graduate of UCLA.