Verification and Validation - Product, Equipment / Process, Software and QMS

• Understand Verification and Validation, differences and how they work together
• Develop a “Working Definition” of V&V, Qualification, and related terms
• Discuss recent regulatory expectations
• How to document a “risk-based” rationale, and use it in a resource-constrained environment
• Determine key “milestones” and “tasks” in a project; device sample provided
• Locate and document key subject “inputs”
• Compile “generic” Master and Individual Validation Plans
• Lean the key element of a Product V&V File / Protocol
• How to develop Process and/or Production / Test Equipment V&V Files / Protocols
• Basic Test Case / Script construction
• Sample sizes and their justification
• Lean the key 11 elements of Software V&V expected by the FDA and how to document
• See how to compile QMS Electronic Records and Electronic Signatures V&Vs per 21 CFR 11 and related CGMPs

• Regulatory Affairs Departments
• Quality Assurance Departments
• Quality Control Departments
• IT/IS Departments
• Research and Development Departments
• Production Departments
• Manufacturing Departments
• Engineering Departments
• Process Engineers
• Software Engineers
• Project Managers
• Hardware and software vendors, sales and marketing

DAY 1 (10 AM to 4 PM)

• V&V Planning; The Master Validation Plan; The Individual Validation Plan
• “Risk-based” -- Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management
• File Narrative, Hazard Analysis, FTA, 3 FMECAs (Design, Process, Use[r], and a possible 4 th , Software); also GAMP / JETT approaches
• V&V Project Management – “Milestones” and “Tasks”
• Two key input analysis tools – The Process Map / Flow Chart, and the Cause and Effect Diagram (templates supplied)
• Change control and “drawing a line in the sand”
  
  Elements of a V&V File / Protocol:
  • Intro / Purpose / Scope
  • Protocol Material / Equipment
  • DQ or Requirements Specs
  • ASTM2500
  • IQ (or equivalent)
  • OQ (or equivalent)
  • PQs (or equivalent)

DAY 2 (10 AM to 4 PM)

• Develop and Employ Meaningful V&V Files and Protocols for:
  • Products;
  • Process;
  • Production Equipment;
  • Monitoring and Test Equipment;
  • Software;
  • Quality Management System – 21 CFR 11, Electronic Records / Signature

• The FDA’s 11-element software matrix simplifies "as-product", in-product", process and equipment software V&V – what they mean, how to research and how to document

• The QMS, ERP and 21 CFR Part 11 V&V – “Cloud” Issues; “White box” and “Black box” Testing; Basic Test Case Development

• V&V, Senior Management / IP and Limited Company Resources

• U.S. FDA Audit Issues and “Responsible” Documentation

• Interactive Discussions and Q&A Session

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. 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 quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.

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 on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.