Many years ago, I was hired by a biopharma company to develop analytical methods for therapeutic oligonucleotides. When a new colleague warned me about sample loss on LC columns I looked at him with skepticism.… Read more >
In our current series on Validation Protocols, we reviewed Validation Tests that determined whether the ‘chromatographic method’ is valid. In this tip, we’ll discuss a Validation Test that determines whether the ‘chromatographic system’ is valid.
In this week’s tip, we will continue our discussion on configuring tests for the Validation Protocol and learn how to set up the Accuracy Test.
Since the early 2000s and the advent of the first guidance relating to mutagenic impurities developed by the European Medicines Agency (EMA), it has been necessary to assess the risk posed by mutagenic impurities. Although… Read more >
In this week’s Empower tip, we will continue our discussion on Validation Protocols and learn how to set up the Repeatability Test.
On September 1, 2020, Udit Batra became Waters’ President and CEO. Udit brings a wealth of knowledge and experience to Waters, having previously held executive positions at Novartis and Merck KGaA. Most recently, he served… Read more >
A Default String is text that you can create in advance and then select from a list when you are required to provide a reason for creating and/or modifying something in Empower, such as a method. This week, we’ll continue our discussion on Validation Protocols and learn how to create Default Strings.