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Virtual

Jul 17, 2023 12:00 PM - Jul 17, 2023 1:15 PM

(US Eastern Standard Time)

FDA Guidance on Computer Software Assurance (CSA) – A New Validation Paradigm?

Join our expert panel in a discussion about how FDA’s new Computer Software Assurance (CSA) guidance may reduce costs and improve efficiency.

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Overview

This program has been developed in collaboration with the GCP & QA Community, the System Validation Working Group, and the Clinical Research Community as well as the Society of Quality Assurance (SQA).

Starting with a brief history of software validation, this webinar guides participants through the changes and opportunities brought about by the new FDA Guidance on Computer Software Assurance (CSA) released in September 2022, such as the risk framework, error-guessing, unscripted testing, repeatability testing, as well as risk analysis and adequate documentation. Panelists will discuss how the CSA implementation may decrease the cost of validation while increasing efficiency and provide participants with advice on how to implement the CSA into their validation strategy.

NOTE: This webinar is exclusive to DIA members only.

Who should attend?

  • Meeting Designed For:

    • Executive, Leadership, and Management Professionals from Biotechnology, Pharmaceutical, Device, CRO, Regulatory Agency, and Academic Research Sponsors involved in:
      • Clinical Research
      • eClinical
      • Good Clinical Practice
      • IT/Validation
      • Quality Assurance, Control
      • Regulatory Affairs
      • Validation

Learning objectives

  • Learning Objectives

    By the end of the session, you should be able to:

    • Explain CSA and its relationship is to CSV
    • List what is changing and what is staying the same with respect to CSA
    • Detail the types of testing and evidence collection

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