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FDA In Brief

This article was originally published in The Gray Sheet

Executive Summary

Quality systems workshop: Firms should pre-register by June 7 for FDA's public workshop on how to comply with quality systems regulations, according to a Federal Register notice to be issued May 28. Organized by FDA in conjunction with the Office of Regulatory Affairs and the FDA Medical Device Industry Coalition, the workshop's target audience is regulated industry, particularly small businesses. Among the topics to be addressed are: analysis of FDA 483s and warning letters; the relationship between corrective and preventive actions and QSR and QSIT; designing and implementing CAPA; and the role of complaint files in a CAPA system. The workshop will be held July 19 in Dallas, Texas...
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