USP 1221: The Future of Continuous Analytical Procedure Verification

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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. 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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DEADLINE APPROACHING FAST - From CSV to CSA: FDA’s New Approach to Computer Software Assurance

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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. 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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Due to Demand: 50% Summer Sale Extended Until June 30

Additional Regulatory Affairs, GMP, Quality, Auditing, Food and Nutrition courses now included.

Due to Overwhelming Demand: Summer Certification Sale Extended Until June 30 The response to our Summer Certification Sale has been tremendous. Due to continued interest from students, graduates, and industry professionals, AAPS College has extended its 50% Summer Sale on select professional certifications and individual courses until June 30, 2026. Originally available on a limited number of certifications, the promotion has now been expanded to include additional high-demand courses across Regulatory Affairs, Quality Assurance, Compliance, Pharmaceutical Manufacturing, Food, Nutrition, and Health Sciences. Take advantage of this opportunity to save 50% on eligible courses while earning industry-recognized credentials designed to support career growth in regulated and high-demand industries. PRA 101 Introduction to Regulatory Affairs Build a strong foundation in Regulatory Affairs and learn the regulations, pathways, and compliance principles that guide products from development to market. PRA 201 Pharma Regulatory Submissions, Labeling and Product Summaries Gain practical insight into regulatory submissions and learn how pharmaceutical, biotechnology, and health product applications are prepared, compiled, and submitted to regulatory authorities. PRA 205 Regulatory Affairs for Natural Health Products Learn how Natural Health Products are regulated in Canada and gain practical knowledge of licensing, compliance, labeling, and market authorization requirements. PRA 203 Regulatory Affairs Biotech/Biologics Gain practical insight into the regulatory landscape for biologics and biotechnology products, from development and clinical studies to approval and lifecycle management. PRA204 Regulatory Affairs Medical Device Learn how medical devices are regulated and gain practical knowledge of device classification, licensing, compliance, and market authorization requirements. PRA302 Regulatory Affairs Generic Drugs Learn how generic drugs are developed, evaluated, and approved while gaining practical knowledge of regulatory submissions, bioequivalence, and compliance requirements. PRA305 Global Regulatory Affairs Gain a global perspective on Regulatory Affairs and learn how regulatory requirements, submissions, and approval pathways differ across international markets. PRA301 Post Approval Activities and Compliance Learn how to manage post-approval regulatory activities and maintain compliance throughout a product’s lifecycle in today’s highly regulated industries. GMP1001 Introduction to Good Manufacturing Practices (GMP) Level I Build a strong foundation in Good Manufacturing Practices (GMP) and learn the essential quality, compliance, documentation, and manufacturing principles that drive regulated industries. GMP2001 Intermediate Good Manufacturing Practices (GMP) Level II Advance your GMP knowledge and gain practical insight into quality systems, documentation, investigations, risk management, and regulatory compliance in regulated industries. GMP3001 Advanced Good Manufacturing Practices (GMP) Level III Master advanced GMP concepts and gain practical insight into global regulations, international quality standards, inspection readiness, and compliance expectations across regulated industries. MFG1007 Introduction to Pharmaceutical Manufacturing Methods Gain a practical introduction to pharmaceutical manufacturing and learn the processes, technologies, and quality principles used to produce safe and effective products. TWR3009 Technical Writing and Scientific Communication  Develop the skills to communicate complex scientific and technical information clearly, accurately, and effectively for professional and regulatory audiences. MMR1001 Quality Assurance for Cannabis Build a strong foundation in cannabis quality assurance and learn the quality systems, regulatory requirements, testing standards, and compliance practices that support safe and compliant cannabis production. AUD3010 Introduction to Auditing Build a strong foundation in auditing and learn the principles, techniques, and compliance requirements needed to assess quality systems and support regulatory readiness. AUD4010 Advanced Auditing Level II Advance your auditing expertise and learn how to plan, conduct, manage, and report effective audits that strengthen compliance, quality systems, and regulatory readiness. In addition, all individual courses within the following diploma programs are now eligible for the 50% Summer Sale: FNM Food and Nutrition Management Diploma Program Build a strong foundation in nutrition, food management, and wellness while developing the knowledge needed to support healthier individuals, communities, and organizations. FTSQ Food Technology, Safety and Quality Diploma Program Build expertise in food technology, safety, and quality while gaining the practical knowledge needed to support safe, compliant, and high-quality food production. NHS Nutrition, Health and Sport Diploma Program Explore the science of nutrition, health, and physical performance while developing the knowledge needed to support healthier lifestyles and overall well-being. Whether you are looking to strengthen your regulatory expertise, build quality and compliance competencies, or develop specialized knowledge in food, nutrition, and health sciences, this is an excellent opportunity to earn industry-recognized credentials at significantly reduced tuition. Offer valid until June 30, 2026. 50% tuition reduction applies to eligible individual courses only. Interested to know more about AAPS College of Health, Science and Technology? To learn more, call our team at 416-502-2277 or visit us at info@aaps.ca

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