Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

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 ...

This talk will explore method validation in the digital lab using integrated and connected systems. Collecting validation data from various lab systems often involves navigating multiple challenges, ...

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

The Workshop is planned to highlight, review, and discuss issues related to the implementation of XRF methodologies, including addressing recommendations for compliance to technical requirements of ...