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

LAST CHANCE TO REGISTER

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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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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