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 ...
In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...
FDA's quality system regulation (QSR) is often perceived by medical product developers as unnecessary overhead. Software developers, in particular, often see it as a nuisance that delays the ...
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