Avsnitt
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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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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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Saknas det avsnitt?
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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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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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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.
