Do I receive a certificate after completing Leveraging AI in Risk Assessment for Smarter Computer Systems Validation?

Yes, a certificate of completion is included with your registration.

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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.

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1.5 hours

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

Leveraging AI in Risk Assessment for Smarter Computer Systems Validation

Quantity

Recording – 1 Viewer

$290.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

Defining risk for GxP systems and the 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

Explaining AI-supported risk decisions during FDA inspections

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assessment sits at the center of computer systems validation, yet many organizations still rely on subjective scoring, outdated templates, and assumptions that no longer reflect how modern GxP systems behave.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

Limits of Traditional Scoring and the CSV-to-CSA Transition

12 min

Machine Learning Signals for Failure Likelihood and Criticality

12 min

Building Objective, Defensible Risk Assessment Models

12 min

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.

45+ Years CSV Experience21 CFR Part 11 Co-DeveloperIndependent FDA Consultant

Quantity

Recording – 1 Viewer

$290.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

Topics

AI Risk Assessment Computer Systems Validation CSA GAMP 5 GxP FDA Data Integrity

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