Rentschler Biopharma, a German CDMO, was cited by the FDA with a Form 483 following an inspection that revealed nine observations focused on procedural gaps and records keeping. FDA inspectors visited ...

At its core business process management is the administrative activities aimed at (1) defining a process, (2) establishing responsibilities, (3) evaluating process performance and (4) identifying ...

The manufacturing process is a complex one that can be impacted by many factors: supplies, equipment, factory overhead, the need for special parts, and the people who work at all points in the process ...

Will Kenton is an expert on the economy and investing laws and regulations. He previously held senior editorial roles at Investopedia and Kapitall Wire and holds a MA in Economics from The New School ...

Manufacturing processes are undergoing a transformation every bit as profound as the original industry revolution. Data science, artificial intelligence, additive manufacturing and other technologies ...