Computer System Validation
A comprehensive, hands-on training program designed to equip professionals with the knowledge and practical skills needed to validate computerized systems in regulated life sciences environments. This course bridges regulatory requirements with real-world implementation, ensuring you can effectively manage validation projects from planning through ongoing compliance.
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500.00 USD
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Course Lessons
1. Module 1: Foundation of CSV
Lesson 1.1: Introduction to Computer System Validation
Lesson 1.2: Regulatory Framework Overview
Lesson 1.3: Key Terminology and Concepts
2. Module 2: Validation Lifecycle Methodology
Lesson 2.1: GAMP 5 Framework
Lesson 2.2: Validation Planning Phase
Lesson 2.3: Specification Phase
3. Module 3: Risk Management in CSV
Lesson 3.1: Fundamentals of Risk Management
Lesson 3.2: Applying Risk Assessment to CSV
Lesson 3.3: Data Integrity Risk Assessment
4. Module 4: Testing and Qualification Activities
Lesson 4.1: Development of Test Documentation
Lesson 4.2: Execution of Testing
Lesson 4.3: Specialized Testing Approaches
5. Module 5: Specific System Considerations
Lesson 5.1: Laboratory Systems Validation
Lesson 5.2: Manufacturing and ERP Systems
Lesson 5.3: IT Infrastructure Validation
6. Module 6: Documentation and Reporting
Lesson 6.1: Essential Validation Documentation
Lesson 6.2: Deviation and Change Management
Lesson 6.3: Final Reporting and Approval
7. Module 7: Post-Validation Activities
Lesson 7.1: System Operation and Monitoring
Lesson 7.2: Maintenance and Support
Lesson 7.3: Change Management During Operation
8. Module 8: Audit and Inspection Readiness
Lesson 8.1: Preparing for Regulatory Inspections
Lesson 8.2: Audit Response and Follow-up
Lesson 8.3: Internal Audit Program
9. Module 9: Emerging Trends and Special Topics
Lesson 9.1: Agile and DevOps in Regulated Environments
Lesson 9.2: Advanced Technologies Validation
Lesson 9.3: Global Validation Considerations
10. Module 10: Practical Implementation and Case Studies
Lesson 10.1: End-to-End Validation Project
Lesson 10.2: Common Challenges and Solutions
Lesson 10.3: Career Development in CSV
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