Recent posts

Addressing the Mystery of Sample Loss

By September 24, 2020

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 >

Categories: Columns, PREMIER Blog Series
Tags: , ,

Get Empowered: Method Validation | Tip #192, Validation Protocols: Setting up the System Precision Test in Empower

By September 23, 2020

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.

Categories: Empower Tips
Tags: , , , , , , , , , , , ,

Get Empowered: Method Validation | Tip #191, Validation Protocols: Setting up the Accuracy Test in Empower

By September 16, 2020

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.

Categories: Empower Tips
Tags: , , , , , , , , , , ,

Mutagenic Impurity Risk Assessment Throughout the Development and Manufacturing Process

By September 15, 2020

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 >

Categories: Pharmaceutical
Tags: , , ,

Get Empowered: Method Validation | Tip #190, Validation Protocols: Setting up the Repeatability Test in Empower

By September 9, 2020

In this week’s Empower tip, we will continue our discussion on Validation Protocols and learn how to set up the Repeatability Test.

Categories: Empower Tips
Tags: , , , , , , , , , ,

Five Questions with Waters’ New President and CEO, Udit Batra

By September 2, 2020

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 >

Categories: CEO, Leadership
Tags: , ,

Get Empowered: Method Validation | Tip #189, Validation Protocols: Creating Default Strings in Empower

By September 2, 2020

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.

Categories: Empower Tips
Tags: , , , , , , , , ,