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.
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.
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.
Dr. Mark Argentine, Senior Research Advisor at of Eli Lilly, discusses the benefits of Analytical Quality by Design, the challenges of identifying impurities and drug degradants, and regulatory and compliance barriers to enhance analytical controls.
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.
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.
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.
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.
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.