Most life-sciences firms would agree that the best way to prepare for FDA Warning Letters is to take measures that prevent them from ever coming. Unfortunately, regulatory compliance is a complex beast, and it’s rarely possible to do everything perfectly.
Comprehensive compliance [...] Read More
Your firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.
While it would be nice to prevent such issues [...] Read More