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

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

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