Master Data Integrity for only $99

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Greetings! Data integrity remains one of the most critical pillars of quality, compliance, and patient safety within regulated industries. Regulatory agencies including the FDA continue to place significant emphasis on data governance, with data integrity deficiencies frequently cited in warning letters, inspection observations, and enforcement actions. To help professionals better understand and address these expectations, AAPS Pharma is pleased to present an upcoming workshop focused on the principles, risks, and practical application of data integrity in regulated environments. During this session, participants will gain a comprehensive understanding of data integrity fundamentals, regulatory expectations, and common causes of data integrity failures. The workshop will also explore the ALCOA+ principles, FDA requirements, and real-world examples drawn from warning letters and Form 483 observations. Attendees will learn how to: • Understand the principles and importance of data integrity • Evaluate data integrity compliance within their organizations • Identify common root causes of data integrity failures • Interpret FDA expectations and regulatory requirements • Analyze warning letters and inspection findings related to data integrity • Design systems and processes that support data integrity by design This workshop is particularly relevant for professionals working in Quality Assurance, Regulatory Affairs, Compliance, Quality Control, Manufacturing, and data management functions across pharmaceutical, food, cannabis, and other regulated industries. About the Instructor The workshop will be led by Jason Chu, Director of Operations at AAPS. Jason brings extensive industry experience spanning Quality Control, Analytical Research & Development, GMP compliance, laboratory investigations, process validation, audit response, and corporate training. Prior to joining AAPS, he held several technical and compliance-focused positions at Apotex Inc., including Analytical Research & Development Chemist, Quality Control Chemist, Designated Compliance Coordinator, and Subject Matter Expert supporting Health Canada and FDA audits. In addition to his industry experience, Jason has delivered training on GMP regulations, health and safety, WHMIS, laboratory operations, and data integrity. His background combines hands-on technical expertise with a practical understanding of regulatory expectations, making this session particularly valuable for professionals seeking real-world compliance insights. All participants will receive a Certificate of Attendance upon completion of the workshop.  We look forward to welcoming you to this timely and practical discussion on one of the most important compliance topics facing regulated organizations today. Date & Time Jul 7, 2026 2:00 PM - 3:00 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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FINAL CALL - 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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LAST CHANCE TO REGISTER - 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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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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