Hello, FDA Put AI in a Warning Letter. We Need to Talk.

Join us live for $0 on October 8. Use code SAVE99 to register free.

Greetings! AI JUST BECAME A QUALITY ISSUE. Not theoretically. Not someday. FDA has now cited inappropriate use of AI in pharmaceutical manufacturing. And that leaves Quality teams with a question that’s getting harder to ignore: How much AI-generated work is already entering your Quality Unit? And would your existing quality systems catch it?   SPECIAL WEBINAR ACCESS $99 $0 YES. THIS ONE’S ON US. Join the live webinar at no cost with promo code: SAVE99 October 8 | 12-1 PM EST LIVE • INTERACTIVE • INSTRUCTOR-LED [REGISTER FOR $0]   THE WARNING LETTER WAS THE WAKE-UP CALL. The bigger story is what happens next. AI doesn’t necessarily arrive in a Quality Unit through some huge company-wide implementation.  It can show up much more quietly. DOCUMENTATION AI-assisted drafting REVIEW AI-generated summaries DECISIONS AI-supported analysis “SHADOW AI” Tools being used outside formal systems The technology may be new. Your responsibility for the output isn’t. This is about what happens when AI meets Quality. 🟠WHAT FDA ACTUALLY CITED What made this warning letter different. 🟠WHERE “SHADOW AI” APPEARS How AI can quietly enter otherwise well-run Quality Units. 🟠HOW TO THINK ABOUT AI RISK Because different uses of AI create different considerations.  🟠WHETHER YOUR CONTROLS ARE READY Document control. Attribution. Training. Validation. Review.     THIS CONVERSATION IS FOR YOU IF YOU WORK IN: QA | QC | REGULATORY AFFAIRS | CMC | VALIDATION ONE HOUR. ONE VERY TIMELY CONVERSATION. $99 → $0 USE CODE SAVE99 October 8, 2026 12:00 PM - 1:00 PM EST AI in the Quality Unit: What FDA’s First AI Warning Letter Didn’t Tell You CLAIM MY FREE SEAT Enter SAVE99 at registration to reduce your registration cost to $0. Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

AAPS Pharma | 885 Sheppard Avenue West | Toronto, ON M3H 2T4 CA Unsubscribe | Update Profile | Constant Contact Data Notice