The Method Lifecycle Management Podcast

Waters Corporation
  • 4.6（9則評分）
  • 自然科學

New guidelines from the USP and ICH will facilitate and accelerate adoption of Method Lifecycle Management (MLCM.) Experts will explore a variety of topics to help you understand and adopt MLCM including: key concepts like the Analytical Target Profile, regulatory changes that will impact your workflow, and case studies exploring the application and advantages of MLCM.

  1. 2021/09/23

    Harness the Power of QbD Principles

    In this episode of the Method Lifecycle Management Podcast, join Dr. Pauline McGregor, Consultant and Owner at PMcG Consulting, as she discusses instrument quality by design and its role in the development of a successful AQbD plan.

    31 分鐘

  2. 2021/06/04

    Components of a Successful AQbD Workflow

    Dr. Amanda Guiraldelli-Mahr, Scientific Affairs Manager at the United States Pharmacopeia, discusses the various components of the AQbD workflow including: the analytical target profile, method design, method validation, and performance verification.

    33 分鐘

  3. 2021/04/22

    Janssen's stepwise approach to AQbD and vaccine development

    Waters welcomes back Dr. Ewoud van Tricht where he builds on the last episode when he discussed how Janssen approaches vaccine development with analytical quality by design (AQbD). Today, he elaborates on the specific steps of AQbD and the advantages gained.

    20 分鐘

  4. 2021/03/29

    Applying AQbD Principles to Vaccine Development

    In today's episode, host Arjan Timmerman talks with Janssen senior scientist, Dr. Ewoud van Tricht, about his recent article, "Better Methods for Better Vaccines", and how he approaches vaccine development with an analytical quality by design approach.

    15 分鐘

  5. 2020/06/03

    The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 3

    In our final installment of the nitrosamine podcast series, Dr. Teasdale concludes the topic discussing future regulatory guidance relative to nitrosamines and other mutagenic impurities.

    19 分鐘

  6. 2020/05/18

    The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 2

    In part two of The Nitrosamine Crisis, Dr. Teasdale talks about the challenges in nitrosamine testing and provides advice on facilitating accurate quantitation.

    26 分鐘

  7. 2020/04/23

    The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles – Part 1

    In part one of a 3-part series on the Nitrosamine crisis, Dr. Andrew Teasdale of AstraZeneca discusses regulatory expectations, reporting requirements, and minimizing risk relative to solvent contamination.

    33 分鐘

  8. 2020/03/27

    Data-driven Modeling Approaches to Improve Method Development

    Pfizer's Dr. Pankaj Aggarwal discusses the use of data-driven modeling to build quality and robustness into analytical methods.

    27 分鐘
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4.6
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9 則評分

簡介

New guidelines from the USP and ICH will facilitate and accelerate adoption of Method Lifecycle Management (MLCM.) Experts will explore a variety of topics to help you understand and adopt MLCM including: key concepts like the Analytical Target Profile, regulatory changes that will impact your workflow, and case studies exploring the application and advantages of MLCM.

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