Name: Expert-in-the-Loop AI Quality Risk Management for GxP Validation &amp; Data Integrity with Risk Cortex
SKU: 10457
Price: 999.00 EUR
Availability: InStock

Expert-in-the-Loop AI Quality Risk Management for GxP Validation & Data Integrity with Risk Cortex

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Expert-in-the-Loop AI Quality Risk Management for GxP Validation & Data Integrity with Risk Cortex

Overview

This one-day, on-site instructor-led course introduces the basic skills required to act as an Expert-in-the-Loop™ for AI use in regulated GxP environments and deliver next generation skilling for System Validation, Risk based CSA and QRM.
The cognitive learning programme combines focused lectures, facilitated discussion, polling-based knowledge checks and practical scenario work using RiskCortex Solution.

Attendees will learn how AI, machine learning and large language models are changing validation, data integrity and compliance expectations; how CSV compares to Risk Based CSA and aligns with GAMP® 5 concepts; how QRM principles support Audit Assessment and inspection readiness; and how to apply risk-based critical thinking, mitigation and controls to AI-enabled quality and compliance workflows.

Key topics covered

Attendees will explore the fundamentals of AI technology, with emphasis on how large language models are being used in GxP operations.

The course will explain how AI changes validation, compliance, data integrity and quality decision-making in regulated life sciences environments.

Participants will examine the AI Trust Paradox and learn how Trust by Design™ supports safe and explainable AI adoption.

The programme will compare Computer System Validation (CSV) and Risk Based CSA (Computer Software Assurance), including Agile delivery, SDLC and alignment with GAMP® 5 concepts.

Attendees will learn how QRM (Quality Risk Management) principles, including ICH Q9 thinking, can be applied to AI-enabled processes and controls.

The course will introduce the Expert-in-the-Loop™ role and the critical thinking behaviours needed to provide effective human oversight of AI outputs.

Practical on-site exercises will use RiskCortex Solution scenarios during practicals to help participants work through AI risk assessment, mitigation, control decisions and Audit Assessment readiness.

Who should attend

This course is suitable for quality, validation, CSV, CSA, data integrity, IT, automation, manufacturing, laboratory, regulatory, compliance and operational professionals who need to understand how AI can be used responsibly in GxP environments.
It is also suitable for managers, project leads, business process owners and subject matter experts who may be expected to review, approve, challenge or oversee AI-enabled systems, tools or outputs.

What do Attendees Obtain on Completion?

Attendees who successfully complete the on-site training and associated assignment will receive a completion certificate, in partnership with NIBRT and RiskCortex.

Participants will also gain practical experience from instructor-led scenario work and temporary access to RiskCortex Solution for the assignment activity.

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