Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance 2018 is a seminar that covers topics such as:
- 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
Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance 2018 brings together:
- 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
