GMP Inspections Start Long Before Inspectors Arrive

Early bird pricing available - use code SAVE20 before May 13.

Greetings! One missing signature. One weak investigation. One uncontrolled change. That’s sometimes all it takes for an observation to escalate into a serious GMP concern. As regulatory expectations continue to tighten across pharmaceutical and healthcare manufacturing environments, inspection readiness is no longer optional - it’s operational. This practical 2-hour virtual workshop is designed to help GMP professionals strengthen the exact areas regulators focus on most during inspections. What the workshop covers: • GMP fundamentals and the inspection mindset • GDP and ALCOA+ principles • Deviations, investigations, and root cause analysis • CAPA structure and effectiveness verification • Data integrity expectations and audit trail review • OOS handling and two-phase investigations • Risk-based change control • Validation, qualification, and maintaining the validated state What participants will walk away with: • Practical inspection-readiness tools and checklists • Stronger understanding of regulator expectations • Real-world examples and scenario-based learning • More confidence handling GMP documentation and investigations • A certificate of attendance upon completion Who should attend: • QA and QC professionals • Regulatory affairs professionals • Manufacturing and operations teams • Anyone involved in deviations, CAPA, batch records, or change control • Professionals newer to GMP environments looking to build stronger foundations The workshop will be led by Terry Pilkey, a GMP and regulatory expert with 44 years of experience across both industry and government. Her background includes GMP and Medical Device inspections with Health Canada, along with senior regulatory and quality leadership roles across pharmaceutical, natural health product, medical device, and medicinal cannabis sectors. She currently serves as an executive member and Head of Quality & Compliance at AAPS Pharma. Early Bird Offer: Save 20% by using code SAVE20 before May 13. Date & Time May 29, 2026 2:00 PM - 4:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. 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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A Smarter Way to Build Regulatory & GMP Expertise. 50% Off

Industry-focused, practical training across all levels. Ends May 31

Greetings! If you’re serious about building a career in regulatory affairs or quality within the pharmaceutical, biotech, or natural health product (NHP) industries, this is the month to move. For a limited time, AAPS College is offering 50% off on core regulatory and GMP courses that directly translate into real job skills, not just theory. Start with PRA205 Regulatory Affairs Natural Health Product if you want a clear, practical understanding of how NHPs are regulated across Canada, the US, and global markets. You will learn how product licence applications work, how submissions are structured and managed, what claims are acceptable, and how post-market responsibilities are handled. The course also covers GMP, labelling, audits, adverse event reporting, and real timelines so you understand how things actually move in industry. If you’re entering the industry or want to fix your fundamentals, GMP1001 Introduction to GMP Level I gives you exactly that. It breaks down how quality is built into manufacturing, what good documentation actually looks like, how SOPs function in real environments, and how deviations, recalls, validation, and change control are handled day to day. For those already familiar with GMP, GMP2001 Intermediate Level II goes deeper into Quality Management Systems. You will work through QA and QC concepts, risk management, validation systems, laboratory controls, OOS investigations, and regulatory expectations from Health Canada and the FDA. This is where you move from understanding GMP to actually applying it in a working environment. At the highest level, GMP3001 Advanced Level III focuses on global GMP and regulatory expectations. It covers international standards, ICH guidelines, CTD structure, biologics, cleanrooms, environmental monitoring, and inspection readiness. This is the level where you understand not just compliance, but how global regulatory systems connect. All courses are designed with case studies, real examples, and practical application so you can step into interviews and roles with clarity and confidence. This 50% offer is valid only until May 31. Once it closes, pricing returns to normal. If you’ve been waiting to build real, usable regulatory and GMP skills, this is the moment to act. Explore courses and secure your spot today. Interested in AAPS College of Health, Science and Technology? Register today by calling our team at 416-502-2277 or email us at info@aaps.ca

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

A Smarter Way to Build Regulatory & GMP Expertise. 50% Off

Industry-focused, practical training across all levels. Ends May 31

Greetings! If you’re serious about building a career in regulatory affairs or quality within the pharmaceutical, biotech, or natural health product (NHP) industries, this is the month to move. For a limited time, AAPS College is offering 50% off on core regulatory and GMP courses that directly translate into real job skills, not just theory. Start with PRA205 Regulatory Affairs Natural Health Product if you want a clear, practical understanding of how NHPs are regulated across Canada, the US, and global markets. You will learn how product licence applications work, how submissions are structured and managed, what claims are acceptable, and how post-market responsibilities are handled. The course also covers GMP, labelling, audits, adverse event reporting, and real timelines so you understand how things actually move in industry. If you’re entering the industry or want to fix your fundamentals, GMP1001 Introduction to GMP Level I gives you exactly that. It breaks down how quality is built into manufacturing, what good documentation actually looks like, how SOPs function in real environments, and how deviations, recalls, validation, and change control are handled day to day. For those already familiar with GMP, GMP2001 Intermediate Level II goes deeper into Quality Management Systems. You will work through QA and QC concepts, risk management, validation systems, laboratory controls, OOS investigations, and regulatory expectations from Health Canada and the FDA. This is where you move from understanding GMP to actually applying it in a working environment. At the highest level, GMP3001 Advanced Level III focuses on global GMP and regulatory expectations. It covers international standards, ICH guidelines, CTD structure, biologics, cleanrooms, environmental monitoring, and inspection readiness. This is the level where you understand not just compliance, but how global regulatory systems connect. All courses are designed with case studies, real examples, and practical application so you can step into interviews and roles with clarity and confidence. This 50% offer is valid only until May 31. Once it closes, pricing returns to normal. If you’ve been waiting to build real, usable regulatory and GMP skills, this is the moment to act. Explore courses and secure your spot today. Interested in AAPS College of Health, Science and Technology? Register today by calling our team at 416-502-2277 or email us at info@aaps.ca

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Medical Device Regulatory Pathway (Canada)

A practical look at classification, submissions, and approvals.

Greetings! A medical device rarely gets held back because the science isn’t strong. More often, it’s a decision. A classification that shifts the entire requirement. A document that doesn’t land the way it should. A submission that looks complete, but doesn’t move. From the outside, the pathway in Canada appears structured. Classes are defined, regulations are documented, and the steps seem clear. But once you’re inside the process, it becomes a sequence of calls that determine whether something progresses smoothly or slows down without warning. This 2-hour workshop is built around that reality. It walks through how medical devices are regulated under Health Canada, how risk-based classification actually shapes the pathway, and how market authorization is approached when these decisions are made in practice. The focus is on understanding not just what is required, but how it is applied, where submissions tend to face resistance, and how regulatory strategy supports both approval and what follows after. The session is led by Cecile Cualing, a pharmacist and regulatory affairs professional who has worked across both pharmaceutical and medical device environments. Her experience spans Health Canada, the U.S. FDA, and notified bodies, but what distinguishes her approach is where she started. Her early work in pharmaceutical manufacturing, in formulation and quality control, shaped how she understands regulation today. It is not separate from development or production. It sits within it. That perspective carries through her regulatory work, where she has supported market authorization and lifecycle management in real settings, and it informs how she explains decisions that are often reduced to checklists. All participants will receive a certificate of attendance upon completion. Date & Time May 14, 2026 12:00 PM - 2:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. 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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44 Years in GMP. From Inspector to Industry | Final Chance

Terry Pilkey brings a rare perspective on how GMP actually works in practice.

Greetings! There are very few professionals in the pharmaceutical industry who have seen Good Manufacturing Practices from both sides of the table, and even fewer who have spent over four decades doing it. Terry Pilkey is one of them. With 44 years across government and industry, she has conducted GMP and Medical Device inspections at Health Canada, worked hands-on in chemical analysis, and gone on to lead regulatory and quality functions at Eurofins Biopharma Product Testing Toronto. Her experience spans the full lifecycle of pharmaceutical products, from development through to compliance, audits, and regulatory readiness. Today, as Head of Quality and Compliance at AAPS Pharma, she continues to guide professionals through what GMP actually looks like in practice, not as theory, but as decisions, systems, and consequences that play out in real environments.  It is one thing to understand GMP requirements. It is another to understand how inspectors think, what they look for, and where organizations typically fall short. That perspective only comes from experience at this level. Terry will be speaking on April 30. If you want to understand GMP the way it is applied in the field, this session is worth your time. Date & Time Apr 30, 2026 1:00 PM - 3:00 PM (EST) How is the Workshop delivered? Virtual. Interactive. Instructor-led. 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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