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Compliance Corner: In Today's 24/7 World, Have Experts On Call For FDA Inspections, Eli Lilly Quality Director Says

Executive Summary

Having the right subject matter experts on hand day or night is critical to acing a US FDA facility inspection, Eli Lilly's David Shore advises. In fact, to be sure it always has the right experts available to answer investigator questions, the firm has restructured its organization to include two new roles to support audits: global product stewards and global process stewards.

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