Make Sure SOPs For FDA Inspections Are Robust, Industry Experts Say – And Don't Forget To Train The Receptionist
This article was originally published in The Gray Sheet
In this Gray Sheet "Compliance Corner" feature, Cynosure's Connie Hoy explains how standard operating procedures for FDA inspections are structured at her device manufacturing firm – and urges others to ensure they even have such procedures in the first place. "The purpose of that SOP is to direct the organization toward how you as a company – and the executive management of the company – expect to manage an FDA inspection, or any inspection, for that matter," she says.
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