Inside 'Case For Quality' Forum: FDA Ponders 'Critical-To-Quality' Inspectional Approach

摘要

Steven Silverman has been on a listening tour for more than a year, crisscrossing the country to learn all he can about device manufacturing quality practices.The director of CDRH's Office of Compliance, accompanied by device center staffers, have taken notes from internal and external stakeholders about how firms can be encouraged to make quality a No. 1 concern.