Hello, an OOS Result Just Landed. What Happens Next?

Retest, remeasure, resample, or investigate? Learn how to navigate OOS results in a GMP laboratory.

AN OOS RESULT JUST LANDED WHAT HAPPENS NEXT MATTERS RETEST? REMEASURE? RESAMPLE? Or does doing that create an even bigger compliance problem? ↓ It starts an investigation THE INVESTIGATION FROM THE FIRST RESULT TO THE FINAL CONCLUSION OOS Investigations for Testing Laboratories takes you through the investigation process with a practical, structured approach. 01 IDENTIFY OOS vs. OOT results and the regulatory expectations surrounding them │ 02 INVESTIGATE Phase 1 investigations, hypotheses, remeasurement, retesting and resampling │ 03 DOCUMENT Quality documentation, roles and responsibilities, and defensible investigation records │ 04 CONCLUDE Evaluate findings, report results and determine an appropriate investigation outcome │ 05 PREVENT Use investigation findings and case studies to reduce future OOS occurrences   THE REAL QUESTION “WHY DID IT FAIL?” IS ONLY THE BEGINNING Your investigation must show that the answer was reached scientifically, systematically and compliantly SCIENTIFICALLY SYSTEMATICALLY COMPLIANTLY BUILT FOR THE PEOPLE BEHIND THE INVESTIGATION 🧪 Laboratory Analysts ✓ Quality Assurance 📋 Regulatory Affairs 🔬 Laboratory Supervisors For professionals responsible for investigating, documenting or managing OOS results in GMP-regulated environments WHEN AN OOS OCCURS, CAN YOU DEFEND EACH DECISION? HYPOTHESIS What are you actually testing? REMEASUREMENT When is it scientifically justified? RETESTING When is additional testing appropriate? RESAMPLING When does a new sample make sense?   BE READY BEFORE THE NEXT OOS RESULT ARRIVES. OOS INVESTIGATIONS FOR TESTING LABORATORIES IN A GMP ENVIRONMENT CHOOSE HOW YOU'D LIKE TO LEARN: 👥 Live Workshop Join the instructor-led workshop. ____________ October 19, 2026 JOIN LIVE → ▶️ Recorded Workshop* Learn on your own schedule. ____________ On-Demand Access GET RECORDED ACCESS → 💻 Live + Recorded Workshop* Attend the live workshop and get the recorded version for continued access. ____________ Live: October 19, 2026 Recorded: On-Demand GET BOTH → *Recorded Workshop orders will be processed within 2-3 business days of purchase, independently of the live workshop date. VIEW WORKSHOP OPTIONS → 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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AI + Pharma Quality Webinar: $0 to Attend

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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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