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.
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.
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.
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.
A History of MLCM and How it Will Evolve
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.
Benefits of Applying Analytical Quality by Design to Enhance Analytical Controls
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.
Customer ReviewsSee All
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.