An official with the US Food and Drug Administration (FDA) encouraged the pharmaceutical industry to adopt advanced process control (APC) modeling tools to ensure that manufacturing processes are ...

COLUMBUS, OH – The difference between an anomaly and a defect in product software can be confusing, but it is important to identify which is which to properly handle problems that crop up in product ...

Risk management is a major emphasis of FDA’s new compliance program, the Quality Management System Regulation (QMSR), and companies should expect to see big differences in how the agency will conduct ...

Jordan Elder has served as the Director of Regulatory Affairs at RCA (A Nelson Labs Company) for the last 15 years, providing clients with general direction, tactical objectives, and functional plans ...