Who Should Attend?
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Relevant companies in FDA-regulated industry who need GMP/GLP/GCP compliance
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Drug & biologics
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Plant-derived drugs
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Blood products
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Vaccines
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Animal feed and drugs
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Medical & radiological devices
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Food & additives
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Dietary supplements
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Cosmetics
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Contract research organization
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Computer system or software vendors
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Relevant personnel in the above companies and industries
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Quality assurance personnel
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Quality control personne
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IT specialists
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Validation specialists
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Technical support personnel
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Engineers
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Management who needs a fundamental understanding of CSV
Course Introduction
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.
Course Outline
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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
