Topics
- How to link requirements, specifications, risk management, and testing
- How to use the risk-based validation approach to lower costs
- Reduce testing by writing test cases that trace to elements of risk management
- Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006)
- Proven techniques that reduce software costs and implementation times
- Learn which documents the FDA expects to audit
- Efficiently create validation documentation
- · Increase corporate productivity and individual workforce member productivity
- Make documentation more manageable and understandable
- Decrease resource requirements
- Use resources effectively to perform effective validation while avoiding doing too much
- Avoid 483s and Warning Letters
- How to implement a computer system to gain maximum productivity
Who should Attend
IT, Users of computer systems, QC, QA, Managers, Laboratory staff and Executives.
