The Method Lifecycle Management Podcast

Sep 23 2021 6

The Method Lifecycle Management Podcast artwork

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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Episode 14: Harness the Power of QbD Principles

Sep 23 2021 30 mins

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

Jun 04 2021 33 mins

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.

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

Apr 22 2021 20 mins

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

Mar 29 2021 14 mins

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

Jun 03 2020 19 mins

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

May 18 2020 26 mins

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

Apr 23 2020 33 mins

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

Mar 27 2020 27 mins

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

Nov 05 2019 41 mins

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

Oct 01 2019 39 mins

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.