The Method Lifecycle Management Podcast

Waters Corporation

4.6(9개의 평가)
자연 과학

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.

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.

31분
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.

33분
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.

20분
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.

15분
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.

19분
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.

26분
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.

33분
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.

27분

모두 보기(15개)

예고편

Trailer: Method Lifecycle Management Podcast

Thank you for your interest in the Method Lifecycle Management Podcast. Our aim is to bring together experts in method lifecycle management to discuss a variety of MLCM issues including, key concepts, regulatory drivers, challenges, adoption strategies, and real case studies. Our first episode will air on May 9 and focus on the factors driving adoption of a method lifecycle management approach and the benefits over traditional method management. Please come back on May 9 for our inaugural episode. In the meantime, visit methods.waters.com for educational content dedicated to method lifecycle management.

에피소드 1

•

1분

4.6

최고 5점

9개의 평가

A must for analytical scientists in the pharma industry

2019. 05. 16.

Isabelle Vu Trieu

Phil Borman gives an excellent overview of the drivers behind the Method Lifecycle Management approach, its advantages over the traditional way of developing and validating analytical methods as well as some implementation tips & tricks. Accessible and thorough.

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.

제작진

Waters Corporation
방송 연도

2019년 - 2021년
에피소드

15
등급

전체 연령 사용가
웹사이트 보기

The Method Lifecycle Management Podcast

The Method Lifecycle Management Podcast

Harness the Power of QbD Principles

Components of a Successful AQbD Workflow

Janssen's stepwise approach to AQbD and vaccine development

Applying AQbD Principles to Vaccine Development

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

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

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

Data-driven Modeling Approaches to Improve Method Development

예고편

Trailer: Method Lifecycle Management Podcast

평가 및 리뷰

A must for analytical scientists in the pharma industry

소개

정보

The Method Lifecycle Management Podcast

에피소드

Harness the Power of QbD Principles

Components of a Successful AQbD Workflow

Janssen's stepwise approach to AQbD and vaccine development

Applying AQbD Principles to Vaccine Development

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

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

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

Data-driven Modeling Approaches to Improve Method Development

예고편

Trailer: Method Lifecycle Management Podcast

평가 및 리뷰

A must for analytical scientists in the pharma industry

소개

정보