About the Webinar
The FDA released the long-anticipated Draft Guidance on Computer Software Assurance (CSA) for Production and Quality System Software. The FDA is requesting the industry to provide public comments by November 14, 2022.
Hear directly from the FDA and the FICSA Team, ask questions, and get clarity on the new CSA draft guidance. The FDA Industry CSA Team (FICSA), provided much of the recommendations that went into the CSA draft guidance. The FICSA team is planning an in-person Town Hall from MDIC office in Virginia with the FDA and will broadcast a live webinar.
Takeaways
Walk away with the information necessary for the next step in your journey towards CSA
Gain insight on what you can and should be doing now that the guidance is released
Learn how the new guidance differs from traditional CSV practice
Understand what the guidance means by critical thinking
Recognize importance of performing an effective risk assessment how, where & when do apply
Gain knowledge of how to update modernize your current CSV practice with CSA
Leveraging IT Supplier Assessments While Adopting CSA Principles, what it exactly means