Verification and Validation – Product, Equipment, Software and QMS

Course 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”;

Course Objectives:

• Understand Verification and Validation, differences and how they work together;
• 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;
• 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 construction;
• Sample sizes and their justification;
• Lean the key 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;