Method validation in R&D and QC has evolved beyond statistical evaluation to become a core compliance-driven process. Today, it requires full integration into laboratory operations and the generation ...

This talk will focus on doing method validation work in an environment where data is gathered from laboratory information systems and chromatography data systems. We’ll see how these systems can be ...

The key market opportunities lie in providing training for analytical method validation, focusing on drug substance and product analysis. This includes lab procedure transfer techniques, compendial ...

Producing cGMP biopharmaceutical products requires controlled, consistent performance of the manufacturing process. cGMP also requires controlled, consistent performance of analytical test methods.

Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...