Good Documentation Practices to Support FDA Computer System Validation

Good Documentation Practices to Support FDA Computer System Validation is a webinar that covers topics such as:

  • "GxP" - Good Manufacturing, Laboratory and Clinical Practices
  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Data Archival to ensure security, integrity and compliance
  • 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
  • Learn the requirements for documenting efforts related to systems governed by FDA
  • Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
  • Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
  • Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance

Good Documentation Practices to Support FDA Computer System Validation is intended for:

  • Information Technology Developers and Testers
  • Information Technology Analysts
  • Analytical Chemists
  • QC/QA Managers and Analysts
  • Automation Analysts
  • Laboratory Managers
  • GMP Training Specialists
  • Computer System Validation Specialists
  • Business System/Application Testers
  • Business Stakeholders/Subject Matter Experts
  • Quality Managers, Chemists and Microbiologists
  • Clinical Data Managers and Scientists
  • Consultants in the Life Sciences and Tobacco Industries
  • Regulatory Affairs Personnel
  • Interns Working at the Companies Listed Above

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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