Computer System Validation (CSV) Fundamentals
About Course
This online certification course explains the essential practices of Computer System Validation (CSV) and the GAMP 5 framework. It will provide you with a foundational understanding of how to validate computerized systems to meet global standards like FDA 21 CFR Part 11 and EU Annex 11.
Who Should Enroll:
- IT Professionals working in GxP environments
- Quality Assurance & Regulatory Affairs specialists
- Engineering & Lab Analysts using automated systems
Key Topics Covered:
- Introduction to CSV and GAMP 5
- Applications Need CSV
- Regulatory Guidelines for CSV
- GAMP 5 Guidelines for CSV
- GAMP 5 Compliance in LIMS
- CSV Lifecycle
- 21 CFR and CSV
- CSV Audits
- Questions & Answers on CSV
Course Format:
- Self-paced online modules
- Practical knowledge
- Lifetime access
- Quizzes & certification upon completion
Course Content
Module I
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CSV in Pharma Industry
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Applications Need Computer System Validation
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How to Handle CSV in Pharma Industry?
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Regulatory Guidelines for CSV
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Pre Assessment-1
Module II
Module III
Module IV
Earn a certificate
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