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;