Computer Software Assurance (CSA) Principles – Free Webinar

Register for an Upcoming Session

Computer Software Assurance (CSA) is a practical, risk-based approach for ensuring that your systems meet the regulatory requirements for computer system validation (CSV).

In this webinar, based on the FDA’s 2022 draft guidance Computer Software Assurance for Production and Quality System Software, you will learn how your current CSV program can be updated to leverage the principles of CSA.

The webinar begins with an overview of the purpose of Computer Software Assurance and the latest information regarding the status of the FDA’s CSA guidance document.

Then the webinar walks through the CSA approach for identifying a system’s intended use, categorizing the use, identifying software failure risks, and classifying these risks for subsequent assurance activities.  For each step of the CSA process, the webinar provides relatable examples to bring the CSA principles to life.

Next, you will learn how to determine which CSA activities are appropriate for each system and feature to minimize the risks of software failures.  It’s not one-size-fits-all!  With CSA, the attention and effort are placed on the features where the risk is the highest.

And finally, through examination of several real-life scenarios, you will learn how to maintain your systems in a validated state using CSA principles.

Computer Software Assurance Webinar Topics:

  • Computer Software Assurance (CSA) background and status
  • CSA definitions and approach
  • Defining intended use
  • Assessing system and feature risks
  • Determining risk-based CSA activities
  • Maintaining a validated state
  • Cautions! What to watch out for with the CSA approach


Cost: FREE

We are offering this webinar on the following dates: