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

  • 2 August 2019
  • Webinar

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

The 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

The Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA will be held on 2 August 2019.

522-1788 US Dollar
No exhibition
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  • Computer System Validation (CSV) and Data Integrity for Clinical Trials Regulated by FDA - 2 Aug 2019 (86018)

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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