The Method Lifecycle Management Podcast

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Episode 14: Harness the Power of QbD Principles

Thursday, September 23, 2021 • Duration 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.

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Episode 13: Components of a Successful AQbD Workflow

Episode 13

Friday, June 4, 2021 • Duration 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.

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

Episode 4

Wednesday, August 14, 2019 • Duration 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.

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Episode 3: Verification and transfer of compendial methods

Episode 3

Monday, July 1, 2019 • Duration 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.

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Episode 2: Mitigating risk and improving drug quality with MLCM

Episode 2

Tuesday, June 11, 2019 • Duration 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.

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Episode 1: Advantages of MLCM over traditional approaches

Episode 1

Wednesday, May 8, 2019 • Duration 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.

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Trailer: Method Lifecycle Management Podcast

Episode 1

Thursday, April 18, 2019 • Duration 01:05

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 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.

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

Episode 12

Thursday, April 22, 2021 • Duration 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.

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Episode 11: Applying AQbD Principles to Vaccine Development

Episode 11

Monday, March 29, 2021 • Duration 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.

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

Episode 10

Wednesday, June 3, 2020 • Duration 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.

The Method Lifecycle Management Podcast – Details, episodes & analysis

Podcast details

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Related Shows Based on Content Similarities

Apple Podcasts

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The Method Lifecycle Management Podcast – Details, episodes & analysis

Podcast details

Recent rankings

Apple Podcasts

Shared links between episodes and podcasts

RSS feed quality and score

Publication history

Latest published episodes

Similar podcasts and content

Related Shows Based on Content Similarities

Related Shows Based on Content Similarities

Apple Podcasts

Spotify