VERIFICATION AND VALIDATION - PRODUCT, EQUIPMENT / PROCESS, SOFTWARE AND QMS

Description:

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;

AGENDA

Seminar Objectives:

• 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

Who Should Attend:

• 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