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FDA INSPECTOR SPECIALIZATION IN DEVICE AND DRUG GMPs

This article was originally published in The Gray Sheet

Executive Summary

FDA INSPECTOR SPECIALIZATION IN DEVICE AND DRUG GMPs is planned by the agency, Ronald Johnson, director of the Office of Compliance in FDA's Center for Devices and Radiological Health, said at a June 17 session of the Food and Drug Law Institute's Medical Device Update in Washington, D.C. The FDA field organization is "making plans now to require at some level mandatory training and demonstration of proficiency in particular areas [of specialization] leading to a certificate."
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