Leveraging AI in Risk Assessment for Smarter Computer Systems Validation
Apply AI responsibly to CSV risk assessment — build defensible, inspection-ready risk models that align with CSA, GAMP 5, and FDA data integrity expectations.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
What You'll Learn
About the event
About this event
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.
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assessment sits at the center of computer systems validation, yet many organizations still rely on subjective scoring, outdated templates, and assumptions that no longer reflect how modern GxP systems behave. Teams often misapply CSA by speeding validation without strengthening risk logic.
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.
Code: FDB1347
Curriculum
Requirements
- Computer System Validation, QA, Regulatory Affairs, or IT professionals in regulated industries
- Applicable to digital transformation leaders, GxP application owners, and compliance teams
Meet Your Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures. During her career she has provided training on CSV, 21 CFR Part 11, Data Integrity, and many other compliance topics of interest to the life science industries.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
Related Events
Digital Quality Metrics and AI/ML Analytics: Building a Continuous-Improvement Framework that Aligns with Regulatory Expectations
Learn how AI/ML and real-time digital quality metrics build a continuous-improvement framework aligned with FDA regulatory expectations, 21 CFR Part 11, and GAMP®5.
Carolyn Troiano
AI in GMP: What the FDA Is Already Expecting - Before You Ask
FDA already expects GMP compliance for AI systems. Learn how existing validation, data integrity, and oversight rules apply—before regulators come calling.
Dr. Ginette Collazo
HPLC Analytical Method Development and Validation
Master HPLC instrument and method validation to meet US EPA and FDA requirements for pharmaceutical analysis.
Dr. John C. Fetzer