Topics
- Risk-based validation approach to lower costs
- Documents the FDA expects to audit
- Documentation with easy to understand fill-in-the-blank templates for a computer system validation project
- Specifications, requirements, testing and risk management
- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation
- Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006)
- Reduce testing by writing test cases that trace to elements of risk management
Who should Attend
Attendees from QA, IT, Laboratories, QC, GMP, GCP, GLP professionals and Managers.
