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

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Want to Ask the Instructor Directly? Last Chance to Join Live

GMP in Practice is live September 24. Recorded access is also available on demand.

GMP in Practice: What Inspectors Expect for 2026 Greetings! There’s a strange thing about GMP. Everything can look perfectly compliant... until someone starts asking why. AN INSPECTOR ASKS: Why was this deviation closed this way? Why does the SOP say this, but the team does that? Why was this change made? Where’s the record? And suddenly, compliance isn’t about knowing the rules anymore. It’s about whether your systems can stand behind them. That’s the thinking behind GMP in Practice: What Inspectors Expect for 2026. WHAT WE’LL GET INTO SOPs & Documentation Deviations & OOS QA/QC Validation Change Control Inspections & Audits Because good GMP isn’t just about having the right answers. It’s about being ready for the next question. WANT TO BE PART OF THE CONVERSATION LIVE? The recorded workshop is also available on demand for those who prefer to learn on their own schedule. But if you’d like to engage directly with the instructor during the session, ask questions in real time, and follow the discussion as it unfolds, this is your final opportunity to join us live. Thursday, September 24 | 2:00 PM - 4:00 PM EST CHOOSE HOW YOU'D LIKE TO LEARN: Live Workshop Join live  for the instructor-led workshop. Recorded Workshop* Learn on your own schedule with the recorded workshop. Live + Recorded Workshop* Get both formats together for less than purchasing them separately. *Recorded Workshop orders will be processed within 2-3 business days of purchase, independently of the live workshop date. Whether you work in QA, regulatory affairs, manufacturing, documentation, product development, or another regulated function, this is a chance to learn from someone who has spent decades inspecting GMP, auditing it, and helping organizations put it into practice. All participants will receive a Certificate of Attendance upon completion. WORKSHOP SCHEDULE & ACCESS Live: Sep 24, 2026 2:00 PM - 4:00 PM (EST) Recorded: On-Demand Access (Processed within 2-3 business days) Workshop Options Live & Instructor-led | Recorded | Live + Recorded VIEW WORKSHOP OPTIONS 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