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

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

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

The notion that the role of Quality Assurance (QA) in clinical development should be relegated to reviews, audits and quality control (QC) checks is an