How Has Risk Changed for the Biopharmaceutical Industry in Light of Recent Events?
Risk is still an important issue, and the fundamental premise is that there is so much to do. The science is so complex. The regulatory
What Are FDA’s Thoughts on Quality Culture?
I want to begin before I turn it over to Ken and talk a little bit about FDA’s thoughts on quality culture. I think this
Risk Management and Data Integrity: Focusing on the Critical
The FDA has long taken a risk-based approach to manufacturer GMP compliance expectations and enforcement actions, as well as requiring pharmaceutical and medical device manufacturers