Emerson Exchange 365

Gary Mitchell Senior Industry Consultant – Life Sciences In the 4:42 video, Life Science Drug Process Development and Manufacturing , Emerson’s Gary Mitchell highlights the changes occurring for pharmaceutical and biotech manufacturers. Gary opens noting how these manufacturers are challenged to respond to new methods for drug process development and manufacturing. The U.S. Food and Drug Administration (FDA) is driving manufacturers in the Life Sciences industries to base their development efforts on science, process understanding and a risk-based approach. In response, these manufacturers are embracing new methods such as Quality by Design (QbD) , process analytical technology (PAT) and continuous process verification (CPV) . Under these methods, manufacturers no longer validate processes by proving quality is repeatable. Instead, they must understand the relationships between critical process parameters (CPPs) and their impacts on critical quality attributes (CQAs) . ... Read the full text.