Conference: Analytical Procedure Lifecycle Management (APLM)

Objectives

This track aims to provide a lifecycle-based, risk-driven framework for developing, validating, and maintaining analytical procedures from early development through registration and post-approval change. Participants will learn how to apply current USP updates and use practical case studies (ATP, risk assessment, MODR, validation strategies, precision/replication, platform methods, and OPPV) to define fit-for-purpose validation scope, ensure method robustness and independence, and manage changes in an inspection- and dossier-ready way.