Leveraging AI in Risk Assessment for Smarter Computer Systems Validation

INSTANT WEBINAR STREAMING

Leveraging AI in Risk Assessment for Smarter Computer Systems Validation

Risk models often rely on static scoring that no longer reflects how interconnected GxP systems behave across validation, release, and ongoing operation decisions. This session establishes a structured method to incorporate AI-based signals into validation risk assessments, strengthening evidence trails and maintaining consistent CSA-aligned reasoning.

Designed for professionals accountable for validation logic, electronic records integrity, and documented risk rationale across system lifecycles.

Course Rating by 93 Learners

How This Session Is Structured

The program begins by reframing risk definition for modern GxP systems, then progresses into structured use of machine-learning signals within assessment models. It connects AI outputs to SDLC decision points, GAMP 5 (Second Edition) guidance, and Part 11 considerations, concluding with practical approaches for ongoing monitoring and inspection discussion readiness.

Key Areas Covered:

Risk definition for GxP systems and limits of traditional scoring
Applying AI-based signals to likelihood and criticality judgments
Integrating AI outputs into CSA-aligned SDLC decisions
Aligning AI-informed assessments with GAMP 5 (Second Edition)
Data integrity reasoning and 21 CFR Part 11 considerations
Continuous risk monitoring using operational system data
Explaining AI-supported risk decisions during FDA inspection discussions

Course Director

Carolyn Troiano

Carolyn Troiano brings over 30 years of computer system validation experience across pharmaceutical and medical device environments. She has developed validation programs since the early FDA guidance era and collaborated on 21 CFR Part 11 discussions. Her background in large-scale IT implementations positions her to address how AI-informed risk assessment integrates into real validation programs under regulatory scrutiny.

What Happens After You Reserve Your Seat

Your registration is managed by our events team to ensure a coordinated and seamless experience.

A confirmation email outlines onboarding details and next steps
Access credentials are shared in advance so you are prepared before the session
Handouts (where applicable) are provided ahead of time
The training is delivered live via Webex with interactive participation and Q&A
Certificates of completion are issued following the session
For live + recording access, post-session availability is provided through TalkFDA
Event support remains available for any access or logistics assistance

Access is provided in a structured and professionally supported format.

A confirmation email outlines onboarding and next steps
The complete session recording is delivered through TalkFDA
Access is granted shortly after purchase so you can begin without delay
Recording includes the full presentation and instructor-led discussion
Certificates of completion are issued upon course completion
Support remains available for any technical or access assistance

For Teams Seeking Deeper Implementation Support

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

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