In our most recent Method Lifecycle Management webinar held Improving Analytical Method Performance Through Quality Risk Management and a Design of Experiments Approach, Joseph A. Turpin, Director of Chromatography Products and Services at S-Matrix Corporation and Tran Pham, Business Development Manager at Waters Corporation, presented an overview of Quality by Design approaches to analytical method development (AQbD), the regulatory views on this approach, examples of design of experiments in AQbD, and case studies demonstrating software assisted AQbD method development.
Waters recently surveyed 100 method developers from innovator and generic pharmaceutical companies to better understand their existing challenges and views on Method Lifecycle Management (MLCM). We’ll share with you the top questions and findings from our survey results.
Halting a chromatographic analysis where the system is not performing correctly or when another error is evident in the separation is a valuable and scientific way to avoid creating unusable data that needs to be subsequently invalidated following a defined analytical lab error/result SOP. But what do you do with that orphan data?
“Assuming continuous improvement is a worthy goal, there is every reason to improve validated chromatographic methods if you’re working with the right instrument technology,” says Eric Grumbach of Waters. See what that means for developing and transferring methods for biologic drugs.
We’ve updated our UPLC systems to enable you to find faster, simpler, and better ways to do your work. Take a closer look at our new and improved ACQUITY UPLC PLUS Series.
One scientist at a major global pharma company estimated that an analytical method could see up to 100 transfers in its lifetime. Increasingly, such transfers will take place across geographic borders. How ready are you to mobilize your methods?
Is your analytical method bound for the lab down the hall, or the lab halfway around the world? If you’re an analytical or QC scientist, get ready for more method transfers between organizations. We explore the complexities of analytical method transfer in part 2 of our ongoing series.
There’s a new analytical testing landscape taking shape, and it’s having a big effect on how we develop, transfer, and update methods. Data quality and business efficiency are both at stake. Are you ready?
How WEQAS is expanding their capabilities with a Waters Xevo TQ-XS Many laboratories participate in external quality assurance proficiency programs, which enable them to compare their results to those of other laboratories. This is essential… Read more >