Data Governance for Computer Systems Regulated by FDA 2019 is a webinar dedicated to FDA’s regulatory expectations for classifying, assessing the risk, testing.
Topics
- Data Governance
- Data Integrity
- Computer System Validation (CSV) Methodology
- FDA GxPs (GMPs, GLPs, GCPs, GDPs)
- Risk Management
- System Development Life Cycle (SDLC) Framework
- Compliance Strategy
- GAMP 5
- Industry Best Practices
- Cost vs. Compliance
- Training
- Policies and Procedures
- Leveraging Vendors
Who should Attend
- Data "Stewards"
- Data "Owners"
- Information Technology Developers and Testers
- Information Technology Analysts
- Clinical Data Managers and Scientists
- QC/QA Managers and Analysts
- Compliance and Audit Managers
- Analytical Chemists
- Automation Analysts
- Laboratory Managers
- GMP Training Specialists
- Computer System Validation Specialists
- Business Stakeholders/Subject Matter Experts
- GLP Training Specialists
- Business System/Application Testers
