Virtual Town Hall

FDA Final CSA Guidance Released:
The Journey, Changes, & What It Means Now

Nov 13, 2025, 11:00 AM – 12:30 PM EST

The FDA’s Final CSA Guidance represents a significant step in modernizing validation across the industry. While it brings clarity, many questions remain about interpretation, practical application, and alignment with existing quality frameworks.

To address these, the FICSA Team, collaborating with the FDA since 2015, premiered a town hall on November 13, 2025, 11:00 AM–12:30 PM EST, where members of the team answered the questions submitted by the registrants and shared key updates and practical guidance.

About FICSA (FDA Industry CSA) Team

FICSA Team, a collaborative industry group that has worked alongside the FDA since 2015 to shape the evolution of Computer Software Assurance (CSA). Through collaboration, education, and open dialogue, FICSA continues to bridge regulatory intent with practical, risk-based validation strategies that drive innovation, compliance, and digital transformation across the life sciences ecosystem.