The FDA Compliance and Clinical Trial Computer System Validation 2016 is dedicated to FDA requirements for clinical trial Computer System Validation (CSV).
The FDA Compliance and Clinical Trial Computer System Validation 2016 covers topics such as:
- The System Development Life Cycle (SDLC) approach to validation
- FDA requirements for clinical trial Computer System Validation (CSV)
- How to build a complete validation strategy and program for clinical trial systems
- GAMP 5 system classification and risk methodologies for categorizing systems and developing a validation pathway
- Know how to monitor a clinical trial system that is in production, governing the data and system through retirement
- How to manage the validation process and create FDA-compliant documentation
- How to measure cost vs. compliance risk for a clinical trial system
- The roles and responsibilities required to validate a clinical trial system
- Good project management principles, incorporating business process re-engineering and organizational change management into the process
The FDA Compliance and Clinical Trial Computer System Validation 2016 brings together:
- 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 System/Application Testers
- Business Stakeholders/Subject Matter Experts
