In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...
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 ...
Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This ...