DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...

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 ...

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, ...

LC-MS/MS has been increasingly adopted by clinical laboratories due to the potential it has for increased sensitivity and specificity over more commonly used analytical techniques. However, ...

The Medical Validation Procedure is very critical to verify that the system offers repeatability, assurance of accuracy, and a high degree of quality, according to a release from MTMS. The company ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.