Your SOP Says One Thing. But What Actually Happens?

Because compliance gets interesting when someone starts asking “why?”

GMP in Practice: What Inspections 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 Inspections 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. 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

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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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Hello, This Fall, Go Deeper Into Regulatory Affairs

Choose the area of regulatory practice most relevant to your career and build focused expertise.

There’s Always That One Area You Want to Know Better. If you work in or around Regulatory Affairs long enough, it happens. A conversation turns to CMC and you realize you’d like to understand it beyond the part you normally deal with. A submission raises questions about labelling. Your work starts touching biologics or medical devices. Or you simply become curious about an area you haven’t had much reason to explore before. That doesn’t necessarily mean you need another full program. Sometimes, one course is enough to go deeper into something that matters to your work, or where you’d like your career to go next. That’s the thinking behind what we’re doing at AAPS this fall. Through September 30, our individual Professional Regulatory Affairs courses are available at 50% of their regular course fees. Individual courses include: PRA101 | Introduction to Regulatory Affairs PRA201 | Pharma Regulatory Submissions, Labeling and Product Summaries PRA202 | Regulatory Affairs for Clinical Research and Preclinical - Drugs PRA203 | Regulatory Affairs Biotech/Biologics PRA204 | Regulatory Affairs Medical Device PRA205 | Regulatory Affairs Natural Health Product PRA301 | Post Approval Activities and Compliance PRA302 | Regulatory Affairs Generic Drugs PRA303 | Intellectual Property PRA304 | Chemistry, Manufacturing and Control PRA305 | Global Regulatory Affairs Maybe you already know exactly which one you’d choose. Maybe there are two or three you’ve been meaning to understand better. Either way, start with what’s useful to you. Interested in AAPS College? Register today by calling our team at 416-502-2277 or email us at info@aaps.ca.

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