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Duties and Responsibilities of the Quality Assurance Unit
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Item Number: NWRR4051
A procedure that defines the duties and responsibilities of the Quality Assurance Unit as they apply to a nonclinical laboratory study. This procedure applies to all nonclinical laboratory studies that support or are intended to support applications for products regulated by the Food and Drug Administration (FDA). This eight-page document discusses the QA Unit’s duties and responsibilities with respect to training of study personnel; study documentation; audits of studies, testing facility, and final report; status reports; QA statement; and maintenance of study documentation.
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