The Method Lifecycle Management Podcast

Waters Corporation

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.

15 Episodes

Episode 14: Harness the Power of QbD Principles
9/23/2021
30:59
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.
Episode 13: Components of a Successful AQbD Workflow
6/4/2021
33:06
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.
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Episode 12: Janssen's stepwise approach to AQbD and vaccine development
4/22/2021
20:24
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.
Episode 11: Applying AQbD Principles to Vaccine Development
3/29/2021
14:56
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.
Episode 10: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 3
6/3/2020
19:27
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.
Episode 9: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 2
5/18/2020
26:08
In part two of The Nitrosamine Crisis, Dr. Teasdale talks about the challenges in nitrosamine testing and provides advice on facilitating accurate quantitation.
Episode 8: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles – Part 1
4/23/2020
33:13
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.
Episode 7: Data-driven Modeling Approaches to Improve Method Development
3/27/2020
27:27
Pfizer's Dr. Pankaj Aggarwal discusses the use of data-driven modeling to build quality and robustness into analytical methods.
Episode 6: A History of MLCM and How it Will Evolve
11/5/2019
41:43
In Episode 6, Dr. Phil Nethercote discusses the factors that led to the beginnings of MLCM and QbD in 2004; his early days at GSK and the implementation of MLCM; and how Method Lifecycle Management might evolve.
Episode 5: Benefits of Applying Analytical Quality by Design to Enhance Analytical Controls
10/1/2019
39:45
Dr. Mark Argentine, Senior Research Advisor of Eli Lilly, discusses the benefits at Analytical Quality by Design, the challenges of identifying impurities and drug degradants, and regulatory and compliance barriers to enhance analytical controls.

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The Method Lifecycle Management Podcast

Waters Corporation

15 Episodes

Episode 14: Harness the Power of QbD Principles

Episode 13: Components of a Successful AQbD Workflow

Episode 12: Janssen's stepwise approach to AQbD and vaccine development

Episode 11: Applying AQbD Principles to Vaccine Development

Episode 10: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 3

Episode 9: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 2

Episode 8: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles – Part 1

Episode 7: Data-driven Modeling Approaches to Improve Method Development

Episode 6: A History of MLCM and How it Will Evolve

Episode 5: Benefits of Applying Analytical Quality by Design to Enhance Analytical Controls