Hello, Inspection Readiness Starts Before the Inspector Arrives

GMP observations rarely come from one major failure. More often, they begin with small gaps that were never addressed.

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. Date & Time May 29, 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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50% Off Until May 31 | Regulatory Affairs for Natural Health Products

Learn more!

Greetings! Natural Health Products continue to be one of the fastest-growing segments across the healthcare and wellness industry - but bringing compliant products to market requires a strong understanding of regulatory expectations, licensing pathways, GMP requirements, and post-market obligations. For a limited time, AAPS College is offering 50% OFF the PRA205 Regulatory Affairs Natural Health Product course until May 31. This practical regulatory affairs course is designed to help professionals and aspiring regulatory specialists build a strong working understanding of the Natural Health Product (NHP) regulatory landscape across Canada, the United States, and key international jurisdictions. Participants will explore critical areas including: • Product Licence Applications (PLA) • NHP classification and submission requirements • GMP and Quality Assurance expectations • NHP labelling and packaging regulations • Claims and advertising considerations • Site licensing and submission management • Importation and distribution requirements • Clinical trials and adverse event reporting • Comparative regulatory frameworks across Canada, the US, and the EU Through practical examples and real-world case studies, learners will gain valuable insight into how NHP submissions are managed from product development through post-market compliance. Whether you are working in regulatory affairs, quality assurance, compliance, manufacturing, or looking to enter the Natural Health Products (NHP) and wellness sector, this course provides practical, career-focused regulatory knowledge designed to support success in the regulated health products industry. Offer valid until May 31. Register Now and Save 50% 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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Earn Industry-Recognized GMP & NHP Regulatory Certifications at 50% Off This Month

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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24 Hours Left: Save 20% on GMP Inspection Readiness Workshop

Early Bird pricing expires tomorrow for this practical GMP inspection readiness workshop.

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. 🚨 Early Bird Offer Ends in 24 Hours 🚨 Register before May 13 and save 20% using code SAVE20. The webinar fee is $199 + HST. With Ontario HST (13%), the regular total is $224.87. With the 20% Early Bird discount, your price is reduced to $179.90 including HST (regularly $224.87). 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. 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

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