FDA Software Validation and Verification, Computer System Validation: Step-by-Step – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Aug 08, 2018 | Available All Day | Duration: 60 Min By: Carolyn Troiano

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The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of your manufacturing and quality system software can conjure up a lot of questions. Understanding the actual guidelines and best practices for meeting these requirements isn’t always clear. Your software may be compliant, but you may not be. This webinar provides you answers to the top most Six common software validation and documentation questions asked by the others in FDA regulated industries and express the best practices for meeting the instruction.

The FDA mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated. While ISO (International Organization for Standardization) and SOX (Sarbanes-Oxley) regulations are not as clear about the validation process, they have to need that software development lifecycle processes be followed in areas where they apply because software validation demonstrates evidence which provides a best result of assurance that a specific process will always generate the expected result or output of the given input.

Documentation is required for Regulatory Validation:

  • Software Validation Protocol (Validation Plan)
  • System /Software Requirements Specification
  • Network Diagram
  • Risk Analysis
  • 21 CFR Part 11 Compliance Analysis
  • Verification Protocol (Test Plan)

Session Highlights:

  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • User Requirements Specification (URS) to include high-level needs in language familiar to the user
  • Operational Qualification (OQ)
  • System Acceptance by the user or owner of the system
  • ….. and more

 

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