Webinar Overview

This webinar provides an in-depth examination of the FDA-endorsed Computer Software Assurance (CSA) framework—a modern, risk-based alternative to conventional CSV. CSA emphasizes critical thinking, product quality, and patient safety over exhaustive documentation and redundant testing. Led by industry expert Fabio Pigossi, this session will give insights on key principles of CSA and demonstrate how an agile, science- and risk-driven mindset can unlock measurable efficiencies across your software validation lifecycle.

What You’ll Learn

• How to pragmatically implement CSA within a GxP-compliant quality system
• Clarifying persistent misconceptions between CSV and CSA—and how to address them
• Real-world insights from a CSA pilot deployment, including challenges, outcomes, and lessons learned
• Strategic considerations for quality, IT, and compliance stakeholders adopting an agile CSA approach

Who Should Watch

This session is tailored for validation professionals, QA leaders, regulatory affairs specialists, and IT stakeholders seeking to modernize their validation practices without compromising compliance.