Best Methodlifecyclemanagement Podcasts (2025)

1
Episode 14: Harness the Power of QbD Principles 30:59

3+ y ago30:59

30:59

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.

1
Episode 13: Components of a Successful AQbD Workflow 33:06

4y ago33:06

33:06

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.

1
Episode 12: Janssen's stepwise approach to AQbD and vaccine development 20:24

4y ago20:24

20:24

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.

1
Episode 11: Applying AQbD Principles to Vaccine Development 14:56

4y ago14:56

14:56

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.

1
Episode 10: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 3 19:27

5y ago19:27

19:27

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.

1
Episode 9: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 2 26:08

5y ago26:08

26:08

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

1
Episode 8: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles – Part 1 33:13

5y ago33:13

33:13

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.

1
Episode 7: Data-driven Modeling Approaches to Improve Method Development 27:27

5y ago27:27

27:27

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

1
Episode 6: A History of MLCM and How it Will Evolve 41:43

5+ y ago41:43

41:43

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.

1
Episode 5: Benefits of Applying Analytical Quality by Design to Enhance Analytical Controls 39:45

5+ y ago39:45

39:45

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.

1
Episode 4: Guidance initiatives from the USP and ICH on Method Lifecycle Management 38:48

6y ago38:48

38:48

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.

1
Episode 3: Verification and transfer of compendial methods 27:04

6y ago27:04

27:04

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.

1
Episode 2: Mitigating risk and improving drug quality with MLCM 24:43

6y ago24:43

24:43

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.By Waters Corporation

1
Episode 1: Advantages of MLCM over traditional approaches 48:19

6y ago48:19

48:19

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.…

1
Trailer: Method Lifecycle Management Podcast 1:05

6y ago1:05

1:05

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 adop…

Podcasts Worth a Listen

Methodlifecyclemanagement Podcasts

Podcasts Worth a Listen

1
The Method Lifecycle Management Podcast

Waters Corporation

1
Episode 14: Harness the Power of QbD Principles 30:59

1
Episode 13: Components of a Successful AQbD Workflow 33:06

1
Episode 12: Janssen's stepwise approach to AQbD and vaccine development 20:24

1
Episode 11: Applying AQbD Principles to Vaccine Development 14:56

1
Episode 10: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 3 19:27

1
Episode 9: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles - Part 2 26:08

1
Episode 8: The Nitrosamine Crisis: Controlling Risk by Leveraging MLCM Principles – Part 1 33:13

1
Episode 7: Data-driven Modeling Approaches to Improve Method Development 27:27

1
Episode 6: A History of MLCM and How it Will Evolve 41:43

1
Episode 5: Benefits of Applying Analytical Quality by Design to Enhance Analytical Controls 39:45

1
Episode 4: Guidance initiatives from the USP and ICH on Method Lifecycle Management 38:48

1
Episode 3: Verification and transfer of compendial methods 27:04

1
Episode 2: Mitigating risk and improving drug quality with MLCM 24:43

1
Episode 1: Advantages of MLCM over traditional approaches 48:19

1
Trailer: Method Lifecycle Management Podcast 1:05

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