A webinar sponsored by Astrix   

Date: June 5th

Time: 1:00 PM ET

Presented by: Fabio Pigossi, Delivery Manager Computer Systems Validation, Astrix

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 Attend

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

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.