Webinar: Practical Aspects of Transitioning to UPLC in the QC Laboratory

Sponsored by: Waters Corp

Focused on:

    Date: 21nd September

    Days old: 4886

    Time: London 3PM / New York 10AM

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    Understanding Proposed Changes to USP General Chapter

    This webinar will help you understand the scientific challenges associated with switching your HPLC methods to UPLC, explain the proposed changes to USP Chapter 621 and explain real world application of UPLC within a Pharmaceutical QC laboratory.

    United States Pharmacopeia (USP) General Chapter Chromatography <621> describes the allowed adjustments to the chromatographic system when a system suitability test fails. The adjustments described in the System Suitability section of Chromatography <621> include the maximum variations that can be made without the need for validation. Maximum allowable changes include such parameters as column length (± 70%), column diameter (± 25%), particle size (± 50%) and flow rate (± 50%). However, a Stimuli Article in Pharmacopeial Forum 35(6) [Nov-Dec 2009] by Neue, et al. proposed changes to Chromatography <621> that allow the analyst to replace a column that is no longer available or take advantage of a more rapid separation while not adversely affecting the chromatographic separation.

    These proposed changes to Chromatography <621> will reduce solvent consumption and decrease analysis time while maintaining or improving the quality of the separation. In this webinar we will describe these proposed changes, the scientific basis behind them and the benefits they can provide.

    The second part of the webinar will focus on the challenges associated with the introduction of new technology into a pharmaceutical Quality Control environment from a business, operational and regulatory viewpoint. It will also discuss a practical approach to overcoming these challenges through the introduction of UPLC into a QC environment at a large pharmaceutical company.

    Presented by

    Douglas McCabe,

    Senior Marketing Manager, Waters Corp

    Mr. Douglas McCabe graduated from the University of New Hampshire with a Master of Science degree in Analytical Chemistry and has been with Waters Corporation for ten years.

    Prior to working at Waters, Mr. McCabe was Applications Manager and Product Manager at ESA, Inc. In his more than twenty years of chromatographic experience, he has published several papers and posters on HPLC and UPLC® method development.

    A Senior Marketing Manager in Chemistry Commercial Operations at Waters, he is responsible for maintaining, promoting and supporting many of Waters HPLC and ACQUITY UPLC® column brands. Mr. McCabe has been involved in UPLC technology since its inception in 2004 and is responsible for developing chromatographic strategies and solutions designed to facilitate the growth of UPLC technology. Throughout his career at Waters, he has been instrumental in defining, developing and commercializing new particles, chemistries, columns and products which enable successful HPLC and UPLC® separations.

    Rosalinda Devos,

    Project Leader (Quality & Compliance Lab Strategy), Johnson & Johnson

    Rosalinda Devos is Director at Janssen, Pharmaceutical Group of Companies (Johnson & Johnson) as Project Leader for the Quality & Compliance, fostering efficient, effective and compliant improvements.
    Rosalinda started her career at Janssen Pharmaceutica in Belgium more than 19 years ago, in the Pharmaceutical Quality Control department. She took up several responsibilities in both Pharmaceutical Quality Control and Chemical Quality Assurance. In 2001 she was part of the team that introduced Cypher production on the Beerse site leading it to successful BSI and FDA inspections. Between 2004 and 2006 she moved to Cashel, Ireland to lead Quality Assurance into an operational organization supporting the launch and commercialization of patches production.
    In her role as Business Unit Director Medical Devices, Rosalinda lead the ramp down and closure of the Cypher operations in both Beerse and Latina without detriment to customer service and quality of the product.
    November 2008 Rosalinda joined GPSG Distribution & Customer Service department as a Program Management Office Director. She was responsible for communication, change management and integrated project planning in distribution projects.
    Rosalinda holds a Master degree in Industrial Engineering - Biochemistry and a Postgraduate in Business Sciences.

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    Key Learning Objectives

    • Understand approaches to transitioning methods from HPLC to UPLC
    • Understand the proposed changes to USP Chapter 621
    • Learn how UPLC has been successfully implemented within a QC laboratory.
    • A practical approach to overcoming the challenges through the introduction of UPLC

    Audience

    • Project Managers
    • Medical Directors
    • Clinical Supply Managers
    • CRO
    • Logistic Managers
    • Study Managers
    • QA/QC heads
    • Senior Scientists
    • Lab heads
    • Plant Directors
    • Heads of Chromatography
    • Process Development
    • Operations Directors
    • Production Directors