Computer Software Assurance (CSA)

This course is designed to give you a high-level understanding of Food & Drug Administration (FDA) Computer Software Assurance (CSA) (Sept 2022) that has recently been issued as a risk-based approach to establish confidence in the automation used for production or quality systems.

We will learn the background on fruition of CSA, the applicability and usage of evolving technologies and processes, the various methods and testing activities that may be applied to provide objective evidence to fulfill regulatory requirements, such as 21 CFR Part 820, and changes from existing approaches and organizational challenges in implementation.