Medical device manufacturers have a bit of latitude in developing a design control system as long as they meet the minimum criteria delineated in the quality system regulation (QSR). The QSR states ...
Recent FDA enforcement trends (including 2013) reveal that both design control and Corrective and Preventive Action (CAPA) systems are critical elements to sustain FDA inspections. Device ...
Applying model-predictive methods and a continuous process-control framework to a continuous tablet-manufacturing process. Currently, there is a high level of interest in the pharmaceutical industry ...
Bioprocessing is an umbrella term that describes the research, development, manufacturing, and commercialization of products derived from or used by biological systems. For industrial purposes, ...
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