LIVE WEBINAR
Annex 22 and AI Governance for GMP
Human Review, Model Monitoring, and Change Control
- July 15, 2026
- 12 PM Eastern Time US
- 4 PM GMT
- 90 Minutes
- Streaming Available
- 90 Minutes
- Certificate of Completion
Designed for organizations implementing, validating, supporting, reviewing, or governing AI-enabled systems that influence regulated processes or quality outcomes.
ABOUT THE COURSE
As AI-enabled systems become part of regulated operations, organizations must determine how oversight, review, monitoring, and change decisions remain controlled. This session organizes governance activities around human accountability, validation practices, lifecycle monitoring, and operational controls supporting AI use within GMP environments.
The discussion begins with the evolution from traditional validation approaches toward CSA-aligned thinking, then examines how AI-specific governance activities fit within existing quality and compliance structures. Particular attention is given to human review responsibilities, model monitoring activities, change management expectations, data integrity controls, and inspection readiness considerations.
Key Areas Covered
- Human review responsibilities within AI-enabled processes
- Model monitoring and performance oversight activities
- AI governance expectations under EU Annex 22
- CSV, CSA, and GAMP 5 Second Edition alignment
- 21 CFR Part 11 considerations for AI systems
- Managing hallucination, bias, and performance drift
- Change control and lifecycle management practices
Carolyn Troiano
Carolyn Troiano has spent more than four decades working in computer system validation, FDA compliance, electronic records, data integrity, and large-scale regulated technology implementations. Her direct involvement in developing 21 CFR Part 11 guidance, combined with extensive experience validating emerging technologies, provides practical insight into governing AI systems within established GMP and quality frameworks.
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
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