The FDA Compliance and Clinical Trial Computer System Validation 2016 is dedicated to FDA requirements for clinical trial Computer System Validation (CSV).
Topics
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
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 System/Application Testers
Business Stakeholders/Subject Matter Experts
Past Events
FDA Compliance and Clinical Trial Computer System Validation 2016 - 16-17 Aug 2016, San Francisco, California, United States (59991)
Important
Please, check "FDA Compliance and Clinical Trial Computer System Validation" official website for possible changes, before making any traveling arrangements
