This two-day course will introduce the basic FDA compliance requirements of CSV by focusing on the requirement interpretations and using FDA references, industry practices, 483 & warning letter citations. It will additionally provide the attendees with practical skills to develop a computer system validation project by case studies.
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Basic Review of CSV Compliance Requirements
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Scope of CSV and Project Preparations
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Master Validation Plan & Validation Protocol
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Qualifications & Validations
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Installation Qualification
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Operational Qualification
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Performance Qualification
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Validation of Security Controls
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Validation Stress Testing or Worst Case
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Risk Analysis
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Key Considerations
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Tools
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Documentation
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Validation Report & Supporting Documentation
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Change Control & Validation State Maintenance
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Case Study
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Q&A /Wrap-up
