محتوای ارائه شده توسط Larry Hines and Waters Corporation. تمام محتوای پادکست شامل قسمتها، گرافیکها و توضیحات پادکست مستقیماً توسط Larry Hines and Waters Corporation یا شریک پلتفرم پادکست آنها آپلود و ارائه میشوند. اگر فکر میکنید شخصی بدون اجازه شما از اثر دارای حق نسخهبرداری شما استفاده میکند، میتوانید روندی که در اینجا شرح داده شده است را دنبال کنید.https://fa.player.fm/legal
Host Francesca Amiker sits down with directors Joe and Anthony Russo, producer Angela Russo-Otstot, stars Millie Bobby Brown and Chris Pratt, and more to uncover how family was the key to building the emotional core of The Electric State . From the Russos’ own experiences growing up in a large Italian family to the film’s central relationship between Michelle and her robot brother Kid Cosmo, family relationships both on and off of the set were the key to bringing The Electric State to life. Listen to more from Netflix Podcasts . State Secrets: Inside the Making of The Electric State is produced by Netflix and Treefort Media.…
محتوای ارائه شده توسط Larry Hines and Waters Corporation. تمام محتوای پادکست شامل قسمتها، گرافیکها و توضیحات پادکست مستقیماً توسط Larry Hines and Waters Corporation یا شریک پلتفرم پادکست آنها آپلود و ارائه میشوند. اگر فکر میکنید شخصی بدون اجازه شما از اثر دارای حق نسخهبرداری شما استفاده میکند، میتوانید روندی که در اینجا شرح داده شده است را دنبال کنید.https://fa.player.fm/legal
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.
محتوای ارائه شده توسط Larry Hines and Waters Corporation. تمام محتوای پادکست شامل قسمتها، گرافیکها و توضیحات پادکست مستقیماً توسط Larry Hines and Waters Corporation یا شریک پلتفرم پادکست آنها آپلود و ارائه میشوند. اگر فکر میکنید شخصی بدون اجازه شما از اثر دارای حق نسخهبرداری شما استفاده میکند، میتوانید روندی که در اینجا شرح داده شده است را دنبال کنید.https://fa.player.fm/legal
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 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.
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.
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.
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.
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.
In part two of The Nitrosamine Crisis, Dr. Teasdale talks about the challenges in nitrosamine testing and provides advice on facilitating accurate quantitation.
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 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.
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.…
به Player FM خوش آمدید!
Player FM در سراسر وب را برای یافتن پادکست های با کیفیت اسکن می کند تا همین الان لذت ببرید. این بهترین برنامه ی پادکست است که در اندروید، آیفون و وب کار می کند. ثبت نام کنید تا اشتراک های شما در بین دستگاه های مختلف همگام سازی شود.