15 episodes
The Method Lifecycle Management Podcast Waters Corporation
-
- Science
-
-
4.6 • 9 Ratings
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
Customer Reviews
A must for analytical scientists in the pharma industry
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.