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Part 11 guidance remains slow-tracked

This article was originally published in The Gold Sheet

Executive Summary

Joseph Famulare, deputy director of CDER's Office of Compliance, said at the Oct. 15 meeting sponsored by Pharmaconference and the University of Rhode Island College of Pharmacy in Bethesda, Md., that "we're on a very slow-moving train with Part 11. We are working on the guidance." Part 11 defines the requirements for the handling of electronic records under GMP requirements
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