Get detailed understanding of how to perform risk assessment as part of 10 step risk based approach to CSV.
Why Should You Attend:
Learn how to perform risk assessment as part of the 10-step risk-based approach to computer system validation. Minimize project time using fill-in-the-blank templates. Ensure compliance with QA, FDA, and clients. What makes this session unique are the real life examples that make application of the techniques understandable in the context of any validation project.
Areas Covered in the Seminar:
- How to use the risk-based approach to reduce validation time and lower costs.
- Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
- Reduce testing by writing test cases that trace to elements of risk management.
- Avoid 483s and Warning Letters.
- Interactive real life examples.
- How to identify risk and establish mitigations.
- Determine risk in a process to reduce the testing effort.
Who Will Benefit:
- Computer System users
- IT
- QA
- Managers
Instructor Profile:
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation - Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 192 mission critical software validation projects.
