LAST CHANCE: 50% Off Until May 31 | Regulatory Affairs for Natural Health Products

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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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Explore the New AAPS Pharma Website + Get 15% Off

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Greetings! We’re excited to celebrate the launch of the newly updated AAPS Pharma website! Our refreshed website makes it easier than ever to explore practical, industry-focused training for pharmaceutical, regulatory, quality, clinical, and compliance professionals. To celebrate, we’re giving new subscribers 15% off their first workshop or webinar. Visit the new website to explore: Live workshops Recorded webinars Corporate training solutions Professional certificates Training in GMP, Regulatory Affairs, Clinical Research, Data Integrity, Validation, Quality Assurance, Natural Health Products, HACCP, Medical Writing, CSA/CSV, and more Whether you’re upgrading your skills, staying current with industry expectations, or planning training for your team, AAPS Pharma has practical learning options designed for today’s pharmaceutical and life sciences industry. Visit the new website, subscribe, and claim your 15% welcome offer today! Visit AAPS Pharma  Interested in AAPS Pharma? Get in touch by calling our team at 416-628-7575 or email us at info@aapspharma.com

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USP 1221: The Future of Continuous Analytical Procedure Verification

Early bird available until June 1st - save 20% with code SAVE20.

Greetings! Analytical method validation has traditionally been treated as a one-time milestone - completed, documented, and revisited only when issues arise. USP 1221 introduces a major shift away from that mindset and toward continuous, risk-based analytical procedure monitoring throughout the entire lifecycle of a method. Join AAPS Pharma for a practical, industry-focused webinar exploring USP 1221 and what this emerging framework could mean for pharmaceutical QC laboratories, analytical development teams, compliance functions, and GMP-regulated operations moving forward. The session will be led by Kevin Mueller MSc, an AAPS College instructor with over 25 years of pharmaceutical industry experience at Novopharm Ltd. and Teva Canada Ltd. Kevin spent 19 years in supervisory roles across Analytical R&D Stability, QC Finished Product, QC Stability, Method Transfer, and Operational Excellence. His expertise includes compliance, data integrity, laboratory investigations, CAPAs, continuous improvement, and GMP laboratory operations within regulated pharmaceutical environments. This session will provide a clear and practical introduction to: • The purpose and regulatory direction behind USP 1221 • The shift toward lifecycle-based analytical procedure monitoring • How continuous verification differs from traditional system suitability approaches • FDA inspection trends and current laboratory gaps • Risk-based performance monitoring and trending strategies • Control charts, statistical tools, and practical implementation considerations • Readiness strategies for both ATP-linked and legacy analytical procedures • Real-world GMP laboratory applications and implementation challenges With finalization of the chapter approaching, organizations now have an opportunity to proactively prepare rather than react later under regulatory pressure.  This session is designed for QC analysts, QA professionals, compliance teams, analytical development scientists, validation specialists, GMP auditors, regulatory affairs professionals, and others working within pharmaceutical, biotechnology, and contract laboratory environments. All participants will receive a certificate of attendance upon completion of the workshop. Early bird registration is available until Jun 1. Use code SAVE20 to receive 20% off registration. Date & Time Jun 22, 2026 1:00 PM - 2:30 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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Hello, Inspection Readiness Starts Before the Inspector Arrives

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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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From CSV to CSA: FDA’s New Approach to Computer Software Assurance

Early bird available until May 31 - save 20% with code SAVE20.

Greetings! The FDA’s February 2026 CSA guidance marks a major shift in how computerized systems are expected to be validated across pharmaceutical and regulated environments. The focus is no longer on excessive documentation for the sake of compliance, but on a smarter, risk-based approach centered around intended use, critical thinking, and modern software realities. Join AAPS Pharma for an in-depth live webinar exploring how Computer Software Assurance (CSA) is reshaping traditional CSV practices, what this means for pharmaceutical and quality operations, and how organizations are expected to approach validation moving forward - including emerging applications involving AI and machine learning systems. The session will be led by Mr. Ashish Kulkarni, a GMP and validation professional with 16+ years of hands-on pharmaceutical industry experience across operational readiness, facility startup, CQV, CSV, automation systems, and large-scale project execution within biotech and pharma environments. His experience spans Greenfield and Brownfield projects, risk-based validation methodologies, DeltaV, Syncade MES, Chronicle systems, and cross-functional implementation within regulated operations. The workshop will cover: • FDA’s CSA Guidance and regulatory expectations • The shift from CSV to CSA and why the industry is changing • Risk-based validation and intended-use-focused assurance • Exploratory vs. scripted testing approaches • Practical implementation strategies and documentation examples • CSA applications within AI/ML systems and quality operations • Real-world pharmaceutical use cases and regulatory considerations This session is designed for validation, quality, regulatory, and IT professionals working with GxP-regulated computerized systems, along with students and consultants pursuing careers in pharmaceutical compliance. All participants will receive a certificate of attendance upon completion of the workshop. Early bird registration is available until May 31. Use code SAVE20 to receive 20% off registration (Early-bird offer). Date & Time Jun 19, 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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