FDA has now cited AI in pharmaceutical manufacturing. Here’s why that matters.

A free webinar on what FDA’s first AI warning letter means for the Quality Unit.

Date & Time Oct 8, 2026 12:00 PM - 1:00 PM (EST) Workshop Options Live | Interactive | Instructor-led AI in the Quality Unit: What FDA's First AI Warning Letter Didn't Tell You Greetings! There’s been no shortage of conversation about AI in pharma. But in April, something interesting happened. The FDA issued a warning letter with a section titled “Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing.” That was a first. And while it would be easy to see this as one facility getting AI wrong, there’s a much bigger question underneath it: How much AI-generated work is already making its way into Quality without anyone really thinking of it as a Quality issue? AI in the Quality Unit: What FDA's First AI Warning Letter Didn't Tell You In this webinar, we’ll look at what FDA actually cited, where “shadow AI” can quietly appear inside otherwise well-run Quality Units, and how to think about different levels of AI risk. More importantly, we’ll look at the controls you may already have: document control, attribution, training, validation and review, and where they may need to catch up. If you work in QA, QC, Regulatory Affairs, CMC or validation, this conversation is increasingly worth having. And we’re making this one free. Use promo code SAVE99 at registration to bring the regular $99 cost down to $0. REGISTER TODAY Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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