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Home » Major New Risk Management Burden Coming Under Part 11 Revision
Major New Risk Management Burden Coming Under Part 11 Revision
December 5, 2006
The FDA’s long-awaited revision of Part 11, which is now slated for release in the first part of 2007, will impose major new burdens on the pharma industry in the area of risk assessment and management, according to Martin Browning, president of EduQuest and a former FDA official.