This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards. You will learn about what must be done to ensure the system remains in a validated state. In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process.
WHY SHOULD YOU ATTEND
This FDA Compliance training will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.
• Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
WHO WILL BENEFIT
• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• To understand how to create, revise and maintain documentation that is FDA-regulated.
• To understand the many deliverables required to complete a computer system validation effort.
• To understand industry best practices.
• To understand and avoid potential pitfalls.
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