CSV 101 — Foundation Course

A full 15-module course covering the complete Computer System Validation lifecycle, from classification and risk assessment through to testing, reporting, closure, operations, retirement and internal audit:

• 1. GMP & the Life Science Industry
• 2. Typical Life Science Computer Systems
• 3. What Is Computer Systems Validation?
• 4. GAMP 5 — A Risk-Based Approach
• 5. 21 CFR Part 11 — Electronic Records & Signatures
• 6. Validation Planning
• 7. Specifications: URS, FS & Design Specs
• 8. Design Qualification (DQ)
• 9. Configuring & Building Your System
• 10. Verification & Testing: IQ, OQ & PQ
• 11. Reporting & Closure
• 12. System Operations
• 13. System Retirement
• 14. CSA — Computer Software Assurance
• 15. Internal Audit, Self-Inspection & Management Review

Written and delivered by a working CSV consultant, drawing on real, current project experience rather than theory alone.

Not sure where you stand first? Try the free GxP Readiness Planner to see your readiness score and which modules cover your gaps.

Need something tailored to your company's specific systems or processes? Custom training is also available — email admin@compval.com.

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