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. |
