2-day In-Person Seminar: Verification and Validation – Product, Equipment, Software and QMS (Medical Devices)
Venue: Grand Hyatt San Francisco
Location: San Francisco, California, United States
Event Date/Time: Sep 27, 2012 | End Date/Time: Sep 28, 2012 |
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 sandâ€;
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 “inputsâ€;
- 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;