CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See

Modern life-sciences teams are under increasing pressure to deliver systems that work, withstand scrutiny, and don’t drown projects in unnecessary documentation. That’s exactly where Computer Software Assurance (CSA) changes the game — and where most companies still get it wrong. This 90-minute session breaks through the noise and shows you how to build evidence the FDA actually wants to see, not the paperwork we’ve been conditioned to generate. You’ll understand how intended use drives everything, where traditional CSV thinking quietly sabotages speed, and how CSA gives you the freedom to focus on what truly matters: proving your system is fit for its purpose with confidence and clarity.

Across the industry, teams know CSA in theory — but struggle the moment they try to apply it. “How much testing is enough?”, “What does a real risk assessment look like?”, “How do we write requirements that support assurance instead of slowing us down?”. This webinar tackles all of it head-on. You’ll explore how to size effort using smart, defensible risk-based thinking, see how requirements and tests can actually support assurance instead of padding binders, and learn how to align CSA with SDLC and GAMP 5 (2nd Edition) without turning the process into a marathon. The session blends practical examples, real-world scenarios, and clear reasoning — the kind that helps you walk back to your team and actually change how work gets done.

If you work in quality, validation, IT, R&D, operations, or anywhere near a GxP system, this is the one session you cannot afford to miss. You’ll leave with a fresh understanding of what “good evidence” truly looks like — documentation that proves control without unnecessary burden, test strategies the FDA respects, essential data-integrity and Part 11 guardrails, and the kind of inspection-ready CSA package that stands on its own. Whether you’re battling legacy CSV habits, modernizing your validation approach, or preparing for upcoming audits, this course gives you the clarity, confidence, and practical direction to move faster while staying fully compliant. In short: this isn’t validation as usual. This is validation done right.

Areas Covered:

• Understanding GxP systems and intended use
• CSV vs CSA — what actually changes
• Risk assessment for CSA: sizing the effort
• Writing requirements & tests that support assurance
• Documentation that proves control without excess burden
• Using SDLC and GAMP 5, 2nd Edition concepts in a CSA approach
• Essential data integrity (ALCOA+++) & Part 11 controls
• Preparing CSA evidence for FDA inspections

Who Should Attend:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.