Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance 2018

Topics

• CSV Points
• Role of FDA
• GAMP 5
• Why Validation? Its Benefits
• Annex 11
• 21 CFR Part 11 Compliance
• Risk Assessment
• Data Integrity
• CSV Deliverables
• Recent Learnings & Avoiding Warning Letters
• CASE STUDIES ….and More
• SOPs and Best Practices

Who should Attend

• Research and Development
• Quality Control & Quality Assurance
• Regulatory Compliance
• Laboratory
• Validation
• IT/IS & Software Departments
• Documentation
• Production & Manufacturing
• Managers and Supervisors
• Training Departme
• Directors, VP’s, CxO’s, General Managers
• Senior Managers and Team Leaders
• Validation Specialists
• Analytical Chemists
• Regulatory Affairs Managers
• Laboratory Managers and Supervisors
• Consultants and Systems Administrators
• Documentation Specialists & Analysts