Leveraging AI in Risk Assessment for Smarter Computer Systems Validation

This course shows how AI can be applied responsibly to risk assessment in computer systems validation, replacing static scoring with evidence-driven decisions. It equips teams to build defensible, inspection-ready risk models that align with CSA expectations while strengthening data integrity, validation focus, and FDA confidence.

WHY YOU SHOULD ATTEND:

Risk assessment sits at the center of computer systems validation, yet many organizations still rely on subjective scoring, outdated templates, and assumptions that no longer reflect how modern GxP systems behave. As systems grow more complex, traditional approaches struggle to keep pace.

Teams often misapply CSA by speeding validation without strengthening risk logic. Gaps emerge when risk models cannot explain why controls exist, how failure likelihood was assessed, or how data was evaluated—issues that surface quickly during FDA inspections.

This webinar brings practical clarity to using AI as a decision-support tool in validation risk assessment. It sharpens judgment, improves objectivity, and helps teams defend how risk decisions are made, maintained, and explained to regulators.

AREAS COVERED

• Defining risk for GxP systems and limits of traditional scoring
• CSV to CSA transition using AI-supported risk logic
• Machine learning signals for failure likelihood and criticality
• Building objective, defensible risk assessment models
• Integration of AI outputs into SDLC and GAMP 5 (Second Edition) decisions
• Data integrity and 21 CFR Part 11 considerations for AI-assisted risk assessments
• Continuous risk monitoring using operational system data
• Explaining AI-supported risk decisions during FDA inspections

WHO SHOULD ATTEND

• Computer System Validation (CSV) Professionals
• Quality Assurance (QA) Departments
• Regulatory Affairs (RA) Departments
• IT / Information Systems Departments
• Digital Transformation and Automation Leaders
• GxP Application Owners
• Data Integrity and Electronic Records Owners
• Senior Management Responsible for Validation Strategy
• Production Departments
• Engineering Departments
• Operations Departments
• Manufacturing Departments
• Compliance Departments
• Consultants

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.