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The FDA released the long-anticipated Draft Guidance on Computer Software Assurance (CSA) for Production and Quality System Software.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Hear directly from the FDA and the FICSA Team, ask questions, and get clarity on the new CSA draft guidance. The FDA Industry CSA Team (FICSA), provided much of the recommendations that went into the CSA draft guidance.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