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How to Conduct a Hazard Analysis/Risk Assessment-Exercise
This session describes how to perform a hazard analysis as part of the risk-based approach to computer system validation.
Description
Emphasis is placed on aligning the hazard analysis with specification and test cases thereby making the validation effort efficient and minimizing implementation times.
Areas Covered in the seminar:
- Interactive real life examples.
- Review the risk-based approach to computer system validation
- How to relate requirements to specifications and risk assessment
- How to use the hazard analysis to make validation efficient.
- How to document the hazard analysis.
Who Will Benefit:
- IT
- QA
- Managers
- Executives
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 169 mission critical software validation projects.
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