Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11 2015 covers topics such as:
- Step-by-step instructions for performing and documenting a risk assessment
- How to use the risk-based approach to reduce validation time and lower costs
- Avoid 483s and Warning Letters
- How to use the results to reduce testing requirements
- How to identify risk in a process and establish mitigations to reduce liability
Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11 2015 brings together:
- IT personnel
- Computer system users
- Managers
- QA personnel
- Executives