The CSV Lifecycle: From Concept to Retirement
About Course
Computer Systems Validation (CSV) is a regulatory requirement and is important to demonstrate your systems are fit for purpose. This masterclass designed to guide professionals through the end-to-end process of Computerized System Validation (CSV) within regulated life science industries.
Aligning with global regulatory standards like FDA 21 CFR Part 11, EU Annex 11, and the GAMP 5 framework, this course simplify the entire validation journey.
Participants will learn how to navigate a system’s entire lifespan – beginning with the initial GxP assessment in the Concept Phase, moving through the rigorous specification and verification steps of the Project Phase, maintaining control during the Operational Phase, and executing compliant decommissioning in the Retirement Phase.
Who Should Enroll:
- IT Professionals working in GxP environments
- Quality Assurance & Regulatory Affairs specialists
- Engineering & Lab Analysts using automated systems
Course Format:
- Self-paced online modules
- Practical knowledge
- Lifetime access
- Quizzes & certification upon completion
Course Content
Module I
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Introduction to CSV Lifecycle
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Key Principles of GAMP 5
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GAMP 5 Software and Hardware Categorization
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Pre Assessment-1
Module II
Module III
Final Assessment
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