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 ...

Analytical Method Validation work is based on a variety of guidelines and requirements hence being time-consuming and stressful. Reducing this work and improving efficiency while ensuring the highest ...

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

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, ...

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 ...

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 ...