Introduction to Analytical Procedure (Method) Lifecycle Management
05 Mar 2019

The pharmaceutical industry relies on data generated by analytical methods for many critical decisions. Traditional approaches consist of distinct exercises - method development, validation, transfer, verification - with limited understanding of the effect of variation on method performance.

The Method Lifecycle Management (MLCM) approach is a holistic approach encompassing all activities from method development to validation, routine use, change control and retirement of the method. This enhanced approach improves the method understanding and performance, leads to fewer out-of-specifications results (OOS), facilitates method transfer and has the potential to lessen the regulatory burden.

This webinar, presented by Dr. Horacio Pappa, Director of General Chapters, United States Pharmacopeia, and Dr. Alexander Schmidt, Founder and CEO, and Mijo Stanic, Cofounder, General Manager and Technical Director, Chromicent Pharmaceutical Services, will describe the method lifecycle management key concepts, its benefits to drug manufacturers and patients, and the current thinking of the USP, FDA and ICH. Case studies will showcase how this approach is being implemented in the pharmaceutical industry.

Attendees of this webinar will learn the following:

  • How Method Lifecycle Management (MLCM) improves method understanding and robustness, by identifying and controlling the sources of variability.
  • Current thinking of the USP and regulatory bodies with an emphasis on USP proposed chapter <1220>.
  • Concrete examples on the implementation and impact of the lifecycle approach.
Who should attend:
  • Method developers and analytical scientists interested in learning how to implement a lifecycle management approach to analytical methods
  • Managers interested in reducing out-of-spec results, improving method transfer and reducing re-validation costs

Waters