Computer System Validation and Part 11

Date: To be confirmed
Instructor: Dr. Mel Dong
Location: To be confirmed
Contact us for more information: bbc@bluebell-consulting.com

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.

• Basic Review of CSV Compliance Requirements
• Scope of CSV and Project Preparations
• Master Validation Plan & Validation Protocol
• Qualifications & Validations
  • Installation Qualification
    
  • Operational Qualification
    
  • Performance Qualification
    
  • Validation of Security Controls
    
  • Validation Stress Testing or Worst Case
    
• Risk Analysis
  
  • Key Considerations
    
  • Tools
    
  • Documentation
    
• Validation Report & Supporting Documentation
  
• Change Control & Validation State Maintenance
  
• Case Study
  
• Q&A /Wrap-up