Webinar Overview

In April 2026, the FDA issued a warning letter containing a section heading it had never used before: Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing. Most of the industry read it as a story about one badly run facility and moved on.

That reading misses what the letter actually exposed. The regulation FDA cited is decades old and says nothing about AI — which means the gap it revealed is not unique to the firm that was cited.

This session starts there and then answers the question the coverage never got to: when AI in pharma does work, what is it actually doing?

To answer it, we went to two places. The published record — company disclosures, peer-reviewed results, regulatory publications, each figure checked against its primary source. And our own instructors, who work inside major pharmaceutical organizations and told us what their functions are doing day to day.

The two sources do not always agree. Where they diverge is the most useful part of the hour.

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Who Should Attend

Quality Assurance, Quality Control, Regulatory Affairs, Clinical, Supply Chain, CMC and validation professionals at pharmaceutical, biologic, natural health product and medical device organizations, in both Health Canada and FDA-regulated environments.

No technical or AI background is required. This session is built for industry professionals, not data scientists.

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Webinar Outline

This webinar covers the following topics:

• The Enforcement Action: What FDA Cited, and What Most Summaries Got Wrong
• How to Read an AI Claim: Target vs. Result, Vendor vs. Company, Pilot vs. Deployment
• Drug Discovery and Clinical Research: Where Adoption Runs Deepest
• Supply Chain: Inventory Anticipation, Forecasting and Digital Twins
• Quality: What Is Deployed, What Is Published, and Why Those Differ
• Regulatory Affairs: Submission Authoring, and What Regulators Are Running Themselves
• Why Human-in-the-Loop Only Counts When It Leaves Evidence
• Synthesis & Q&A

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Learning Outcomes

By the end of this webinar, attendees will:

• Identify the specific CGMP provision FDA applied to AI-generated documents, and why no new regulation was required
• Describe what is genuinely deployed in five pharmaceutical functions, distinguishing production use from pilots and from vendor claims
• Apply four practical tests — target or result, source, pilot or deployment, baseline — to evaluate any AI claim or vendor proposal
• Explain why AI adoption is disclosed unevenly across functions, and what that means when benchmarking your own organization
• Recognize why a human review step is only a defensible control when it produces an auditable record

All participants will receive a certificate of attendance upon completion of the workshop.

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Note: Registration closes one week prior to the start of workshop. Workshop registration is intended for individual use only. Each registration grants access to one participant. If you plan to attend as a group or company team, please ensure that each participant is registered separately. Group rates and corporate packages are available—contact us for details.

Refunds are only available if cancellation is requested at least 48 hours before the workshop. No refunds will be issued for late cancellations.