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

Posted by Waters Method Lifecycle Management Team on June 4, 2020

 

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.

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

Posted by Waters Method Lifecycle Management Team on May 19, 2020

 

In part two of The Nitrosamine Crisis, Dr. Teasdale talks about the challenges in nitrosamine testing and provides advice on facilitating accurate quantitation.

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

Posted by Waters Method Lifecycle Management Team on May 1, 2020

 

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.

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

Posted by Waters Method Lifecycle Management Team on May 1, 2020

 

Pfizer's Dr. Pankaj Aggarwal discusses the use of data-driven modeling to build quality and robustness into analytical methods.

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Podcast Series Episode 1: Advantages of MLCM over traditional approaches

Posted by Waters Method Lifecycle Management Team on January 2, 2020

 

In our first episode, host Greg Martin of Complectors Consulting talks with Dr. Phil Borman of GSK about the advantages and influences of  method lifecycle management including analytical quality by design, risk assessment tools, ICH guidances, and opportunities to kick off the approach in your organization.

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Podcast Series Episode 2: Mitigating risk and improving drug quality with MLCM

Posted by Waters Method Lifecycle Management Team on January 2, 2020

 

In our second episode, we examine a method lifecycle management approach in monitoring method performance and applying MLCM to address real world issues like nitrosamines (ni-tros-a-mine) in Valsartan.

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Podcast Series Episode 3: Verification and transfer of compendial methods

Posted by Waters Method Lifecycle Management Team on January 2, 2020

 

In Episode 3, Dr. Pauline McGregor discusses how MLCM is applied to the verification and transfer of compendial procedures including the importance of developing, defining, and refining the analytical control strategy.

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Podcast Series Episode 4: Guidance initiatives from the USP and ICH on Method Lifecycle Management

Posted by Waters Method Lifecycle Management Team on January 2, 2020

 

Dr. Horacio Pappa, Director of the General Chapters Department, Global Science Division at USP, discusses the current regulatory landscape, guidance from USP and ICH, and implications for regulatory strategies relative to method lifecycle management. 

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

Posted by Waters Method Lifecycle Management Team on January 2, 2020

 

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

Posted by Waters Method Lifecycle Management Team on December 10, 2019

 

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.

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