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Compliance Corner: Have Tech-Savvy People In Place For 'Live' FDA Inspections

Executive Summary

Device manufacturers should have appropriately skilled individuals fetching and handling electronic information to be handed over to US FDA investigators, says a former Johnson & Johnson quality & compliance expert. "The inspectional front room has to be able to manage live information, which means you have to have people who know the IT tools and how to navigate them, and how to find things quickly and explain them," Teresa Gorecki advises.

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