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.

Highlights

• What’s new in USP <1221>/<1225>
• Risk-based validation decisions
• Practical case studies (ATP, risk assessment, validation strategy, precision/replication, platform procedures, OPPV)

Target Audience

• Laboratory managers, supervisors and analysts,
• Quality control managers,
• Heads of quality control,
• Qualified Persons (QPs),
• Analytical scientists,
• Senior laboratory staff,
• Responsible authorities,
• Service providers (contract research organisations and contract manufacturers).