Risk-Based Computer System Validation -- CS311
advanced insight into the Risk-Based approach
This advanced workshop covers the basics of risk-based validation, and provides a practical set of tools and examples that you can put to immediate use. You will learn the information you need to implement a sound approach in your organization. It will build on your current understanding of computer system validation and will help you to develop a risk-based method.
Topics
- What do the guidelines and regulations say about risk?
- What does FDA mean by a ‘risk-based’ approach?
- How can we measure the risk level of an application?
- How do we document that risk level?
- How can we scale validation effort to the determined risk level of a system?
- How do you revise validation policies and procedures to move to a risk-based framework?
Who Should Attend?
- Directors of Information Technology
- Directors of Quality Assurance
- IT professionals with a basic knowledge of computer system validation
- Quality Assurance professionals who deal with software quality
- IT Project Managers who deal with validated applications
- Validation Team Leads
Prerequisites: Assumes knowledge of computer system validation
Text/Materials Included: Course binder
Duration: 2 day workshop
Professional Development Credits: 16 PDUs
Cost: $1,650
Course Dates and Location:
There are currently no scheduled course dates. Please contact us if you are interested in enrolling in this class.