LIVE WEBINAR
AI in GMP: What the FDA Is Already Expecting – Before You Ask
- June 18, 2026
- 11 AM Eastern Time US
- 3 PM GMT
- 60 Minutes
- Streaming Available
- 90 Minutes
- Certificate of Completion
EXCLUSIVE OFFER: Get your team to attend for just $ 290. Post-Live Q&A and Complimentary Course Replay Included. Individual registration available too.
Designed for organizations evaluating, implementing, managing, or overseeing AI-supported processes that influence product quality, compliance activities, or operational decisions.
ABOUT THE COURSE
As AI-enabled tools become part of GMP operations, organizations must decide how those systems fit within existing quality, validation, oversight, and accountability models. This session organizes current FDA expectations into practical governance, validation, and operational control activities that support consistent AI use across GMP environments.
The session examines how existing GMP requirements already apply to AI-enabled systems, then evaluates the operational controls needed to maintain oversight. Topics progress from governance and validation considerations through risk management, supplier oversight, human accountability, documentation practices, and inspection-focused review of AI-supported activities.
Key Areas Covered
- Applying existing GMP principles to AI-enabled systems
- Governance, accountability, and ownership of AI use
- Validation expectations for AI-supported activities
- Data integrity, audit trails, and output verification
- Managing bias, model drift, and AI-related risks
- Supplier qualification and third-party AI oversight
- Inspection readiness and documentation practices
Dr. Ginette Collazo
Dr. Ginette Collazo specializes in quality systems, human performance, root cause analysis, and operational reliability within GMP-regulated industries. Her work helping organizations build practical governance, investigation, and compliance programs provides direct relevance to AI adoption, where human oversight, decision-making quality, accountability, and system control remain central regulatory expectations.
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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