OCT 28, 2014 7:00 AM PDT

Quality-by-Design Development of a Purity Method Using ACQUITY UPLC H-Class and QDa Mass Detector

Speaker
  • Founders and Managing Directors, Chromicent GmbH
    Biography
      Alexander H. Schmidt has worked 25 years as head of quality control as well as laboratory manager of a development laboratory in a medium-sized, global pharmaceutical company. His expertise lies in the development and validation of analytical methods according to the latest quality-by-design approaches, the qualification of analytical instrument (AIQ), increased efficiency in the laboratory as well as GMP and compliance. Alexander H. Schmidt is the author of more than 50 publications and scientific posters and also a guest lecturer at the Beuth University in Berlin.
       
      Mijo Stanic has worked closely for several years as head of analytical development with Alexander Schmidt. He is an expert in quality-by-design in the development of chromatographic separation methods and mass spectrometry. He is also co-author of numerous publications.

    Abstract

    Pre-recorded webinar available for immediate playback.

    Traditional method development, in which an LC method is developed principally by trial-and-error, is time consuming and may not result in a robust method. In addition, taking this approach provides no understanding of the influence of key factors on the results. Conversely, modern systematic method development strategies using statistical or modeling software tools to generate experimental designs and explore method robustness offer numerous advantages and can provide a fast and efficient approach for method development.

    Chromicent GmbH (Berlin, Germany) managing directors Alexander Schmidt and Mijo Stanic are experts in the development and validation of analytical methods according to the latest quality-by-design approaches. The aim of their recent work has been to apply quality-by-design principles to build in a more scientific and risk-based, multifactorial strategy in the development of a new UHPLC methods. In this webinar, they will describe the application of their approach in the development of a new purity method for a well known API. The final method, with an analysis time of only 4 minutes, provides a 40-fold increase in productivity compared to the existing method published in the European Pharmacopeia.


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