Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA

Topics

• The Computer System Validation (CSV) approach based on FDA requirements
• How to identify GxP Systems
• The best practices for documenting computer system validation efforts, including requirements, design , development, testing and operational maintenance procedures
• The System Development Life Cycle (SDLC) approach to validation
• How to assure the integrity of clinical data that supports trial work
• How to maintain a system in a validated state through the systems entire life cycle
• The policies and procedures needed to support your validation process and ongoing maintenance of your clinical trial systems in a validated state
• The importance of GxP documentation that complies with FDA requirements
• The regulatory influences that lead to FDAs current thinking at any given time
• The key components of 21 CFR Part 11 compliance for electronic records and signatures
• How an electronic Trial Master File (eTMF) can improve trial management
• How to prepare the essential files for a Trial Master File
• How to best prepare for an FDA inspection or audit of a clinical trial related computer system
• The clinical data files that are essential to collect before, during and after the conduct of a trial

Who should Attend

• Clinical Data Managers
• Clinical Data Analysts
• Information Technology Analysts
• Clinical Trial Sponsors
• QC/QA Managers and Analysts
• Information Technology Developers and Testers
• 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
• This seminar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance