The Analytical Procedure Lifecycle: A Modern Approach to Managing Your Methods

Stephanie Harden, Waters Corporation, Baden-Dättwil, Switzerland (stephanie_harden@waters.com)

The pharmaceutical industry relies on data generated by analytical methods for many critical decisions, however, the traditional approach to methods consisting of distinct exercises - method development, validation, transfer and verification - provides limited understanding of the effect of procedural variability on method performance.

The Method Lifecycle Management (MLCM) approach, as proposed in USP <1220> is a holistic approach encompassing all activities from method development to validation, routine use, change control and retirement of the method. This enhanced approach facilitates improved method understanding and performance, facilitates method transfer, can lead to fewer out-of-specifications results (OOS), and has the potential to lessen the regulatory burden.

In this seminar, we will explore some of the key concepts of method lifecycle management and discuss the benefits of adopting a more modern approach to methods.

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Abstract Reference & Short Personal Biography of Presenting Author

Dr Stephanie N. Harden

Pharmaceutical Business Unit Manager & Strategic Partnerships Advisor, EMEIA

Waters Corporation

Stephanie is responsible for the development of Waters’ small molecule pharmaceutical business, the largest revenue-generating market segment within Waters' European organisation.  In this role, she is responsible for planning and coordinating growth strategies to ensure Waters' continued success, and works closely with her internal and external customers, establishing and maintaining partnerships to ensure mutual benefit.

Stephanie is a highly cited researcher and University of Bristol graduate with a PhD in chemistry.
Connect with Stephanie via LinkedIn.