Annex 22 and AI Governance for GMP

Human Review, Model Monitoring, and Change Control

A practical review of EU Annex 22 expectations for AI-enabled GMP systems, including human review, model performance, change control, and validation alignment.

EXCLUSIVE: Get your team to

attend for just $ 390.

Individual registrations available too.

COURSE OVERVIEW & STRUCTURE

AI systems need monitored GMP operating boundaries.

GMP teams must determine how AI-enabled systems are reviewed, monitored, changed, validated, and maintained within regulated operating environments. This session structures Annex 22 expectations alongside CSV, CSA, Part 11, GAMP 5, human review, model monitoring, and lifecycle control.

The session connects Annex 22 requirements with existing validation, data integrity, and software assurance practices. It reviews human review expectations, AI output assessment, model drift, bias, change control, inspection readiness, and the role of qualified experts in maintaining controlled GMP use.

WHAT YOU’LL LEARN

Controlling AI behavior within GMP systems

EU Annex 22 requirements for AI governance
CSV, CSA, and GAMP 5 alignment
21 CFR Part 11 expectations for AI systems
Human review of AI-generated outputs
Model monitoring for bias, drift, and hallucinations
Change control for AI-enabled applications
Expert accountability as the human guardrail
Inspection readiness for AI-supported systems

WHO SHOULD ATTEND

Designed for professionals responsible for validating, supporting, reviewing, auditing, or using AI-enabled GMP computer systems.

Quality Assurance

Computer Validation

Regulatory Affairs

Information Technology

Laboratory Operations

Manufacturing

Automation

Clinical Data

FACULTY

Carolyn Troiano

Carolyn Troiano brings more than 45 years of experience in computer system validation, FDA compliance, Part 11, data integrity, and large-scale IT system implementation. Her participation in the FDA and industry work on electronic records and signatures makes her especially suited to address Annex 22, CSA, AI governance, and inspection-ready system control.

AFTER YOU REGISTER

Everything related to your course lives in one place.

FDB2849

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After you register your seat, our team organizes everything for you; from access to certification – “from one place”.

You receive a confirmation and your course appears instantly in your TalkFDA dashboard.
Your course page becomes your central hub where you can join the session, access materials, and manage your learning.
At the scheduled time, simply click Join Session and you’ll be connected to the live Webex session with the instructor.
After the session, the playback becomes available on the same course page so you can revisit important sections.
Complete the course and your certificate is unlocked automatically in your learning history.

For Teams Seeking Deeper Implementation Support

Customized training is also available through

TalkFDA Elite Training Labs.

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.

Annex 22 and AI Governance for GMP

Human Review, Model Monitoring, and Change Control

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