Computer System Validation (CSV) in the Pharmaceutical Industry
Course Overview
Learn the principles and practical implementation of Computer System Validation (CSV) in regulated pharmaceutical environments. This course covers the validation lifecycle, regulatory requirements, risk-based validation, data integrity, and documentation in accordance with FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP® 5, helping participants ensure compliant computerized systems throughout their lifecycle.
What You'll Learn?
- Understand the regulatory requirements governing Computer System Validation.
- Explain the CSV lifecycle based on GAMP® 5.
- Apply risk-based validation principles.
- Develop User Requirement Specifications (URS).
- Prepare validation plans and validation documentation.
- Understand Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Validate laboratory and manufacturing computerized systems.
- Implement FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.
- Perform supplier assessment and software categorization.
- Conduct risk assessments using pharmaceutical quality risk management principles.
- Manage change control within validated systems.
- Maintain the validated state throughout the system lifecycle.
- Prepare computerized systems for regulatory inspections.
- Recognize common inspection observations and compliance gaps.
- Quality Assurance (QA) Specialists and Managers
- Quality Control (QC) Analysts and Supervisors
- Production Pharmacists and Managers
- Manufacturing Engineers
- Validation and Qualification teams
- Warehouse and Supply Chain Personnel
- Anyone preparing for GMP audits, inspections, or career advancement in pharmaceutical manufacturing.
- Basic knowledge of pharmaceutical manufacturing is recommended.
- Active participation in discussions and case studies is encouraged.
- Complete the final assessment to receive the certificate.
- Student Handbook with Course Presentation Slides including :Workshop Exercises ,Case Studies ,Template protocols ,Audit Checklist ,Reference Guidelines ,Assessment Quiz ,Certificate of Completion.
Course Content
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Day 1: Regulatory framework
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Lesson 2 : GAMP 5 Software Categorization
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Day 2: Computerized system Risk based testing
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Lesson 1: Computerized system Risk assessment
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Lesson 2: Risk-based testing
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Day 3: Operation of Software
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Lesson 1: Computerized system operation requirements
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Lesson 2: Computerized system documentation requirements
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