KPMG | 1 CPE | The FDA’s guidance on Computer Software Assurance (CSA) for life sciences one year later

KPMG | 1 CPE | The FDA’s guidance on Computer Software Assurance (CSA) for life sciences one year later

On September 13, 2022, the U.S. Food and Drug Administration (FDA) issued draft guidance providing recommendations on Computer Software Assurance (CSA) for computers and automated data processing systems used as part of life sciences organizations’ production or quality systems. The guidance would allow for—and even encourage—the industry to adopt a simpler assurance approach that emphasizes critical thinking and assurance needs as opposed to testing and documentation.

Join us for this one-hour webcast in which speakers will have a panel discussion that outlines where is the industry now, a year after the FDA’s guidance on CSA for life sciences organizations. During this event, KPMG as well as other industry leaders will discuss what is the industry experiencing, and where do they think the same is heading in regard to the implementation of CSA to their production and quality systems. 

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