Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning:

  • Start with a Master Validation Plan;
  • Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management;
  • The Individual V&V Plan;
  • V&V Project Management;
  • “Risk-based” per ISO 14971, ICH Q9, and/or GAMP/JETT;
  • Two key input analysis tools;
  • Change control and “drawing a line in the sand”;
  • Develop meaningful V&V Files and Protocols for:
    • Products;
    • Process;
    • Production Equipment;
    • Monitoring and Test Equipment;
    • Software;
    • Quality Management System – 21 CFR 11, Electronic Records / Signatures;
  • The roles of different V&V protocols;
  • How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents,
  • V&V against a background of limited company resources;
  • The FDA's 11-element software matrix simplifies "as-product", in-product", process and equipment, et al, software VT&V;
  • Assure key U.S.FDA and comparable EU MDD / ISO requirements are not overlooked;
  • The QMS and 21 CFR Part 11, “Electronic Records / Signatures” V&V;
  • Hands-on examples and activities show real-world implementation of useful principles, tools and templates;
  • 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