Quality Assurance

FDA Quality Management Maturity Program

January 15, 2024 || Martina McDonagh
Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the patients. These shortages can be for a variety of factors including manufacturing and quality issues. To this end the FDA embarked on the Quality Management…

Quality Mindset on High-Risk Projects

October 7, 2022 || Lana Caperton
From client project kick-off to ribbon cutting, a high-risk project can be controlled if quality behaviors and expectations are exercised and embraced by the Team throughout the process.  Drivers for client projects include getting drug product to more patients at a lower cost (expansion of new process trains and scale…