Risk Management

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

Since 2021, the Pharma Manufacturing World Summit has gathered SVPs and VPs of Manufacturing, Quality, Supply Chain, Technical Operations Executives, and other industry professionals. These

In session 4 of our Executive GxP Training program, Teresa Gorecki discusses understanding and managing the regulatory compliance risks to your business​. The two provide

FDA's Quality culture, a term that has been gaining traction in regulatory compliance, is taking center stage in the life sciences industry. In a recent

Risk is still an important issue, and the fundamental premise is that there is so much to do. With this important issue and ever-changing landscape,

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