Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA 2019 is a conference that covers topics such as:
- 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
Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA 2019 brings together:
- 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
