Product Lifecycle Management: Embracing Quality Systems for Sustainable Operations

摘要

Biopharmaceutical manufacturers have often explored the idea of real-time process control and monitoring — but until relatively recently, few case studies were available to help put all the information together in a coherent plan for true product lifecycle management. Shifting from previous BPI Conference programs that included a "scale-up" track, this year's lifecycle track will reflect how companies are being encouraged to view development, design, and manufacturing as a continuum rather than (more "traditionally") as a set of discrete phases. And continuous improvement throughout a product's lifecycle, including postlaunch activities, is an important goal of these new approaches.