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

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T ...

This course provides candidates with practical tools for validation including, qualification, process validation and analytical method validation. Incorporating facility/equipment qualification, ...

The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the ...

When developing medical device products and the parts that comprise them, engineers must usually decide what elements of the design are critical to function and, therefore, what dimensions require ...