Method Lifecycle Management Webinar Series

Library Number:
WEBC135032517
Author(s):
Amanda Dlugasch, Leonel M. Santos, Dr. Horacio Pappa, Dr. Alexander Schmidt, Mijo Stanic, Tran Pham, Joseph Turpin
Content Type:
On Demand Webinar
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Your analytical method faces many sources of variability over the course of its life. A new approach, method lifecycle management, helps you address risks at each phase of your method’s journey, resulting in more robust performance, lower costs, and ultimately, safer medicines. The following webinars highlight the importance of method lifecycle management

Pharmacopeial Modernization: How Will Your Chromatography Workflow Benefit?

Topics covered in this webinar include:

  • Pharmacopeial monograph modernization prioritization scheme
  • Review of USP General Chapter current allowable adjustments to validated methods and forthcoming updates
  • Case study on the migration of isocratic and gradient pharmacopeial methods to modern column technology, highlighting improved method performance and throughput

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Introduction to Analytical Procedure (Method) Lifecycle Management

Download this webinar and learn:

  • 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.
  • Concrete examples on the implementation and impact of the lifecycle approach.

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Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach

This webinar will give you access to:

  • Benefits of addressing method challenges via risk assessment and design of experiments (DOE) approaches
  • Improvement of method robustness and performance with a DOE approach and QbD method development software
  • Current thoughts around AQbD from the USP, FDA, and ICH

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Continued Performance Verification of Analytical Procedures Using Control Charts in Empower Chromatography Data Software

This webinar discusses and demonstrates the use of Empower 3 Control Charts to facilitate the continued procedure performance verification stage of the analytical procedure lifecycle approach.

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