FDA Inspection Preparation and Management：FDA检查的准备和管理.pptVIP

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FDA Inspection Preparation and Management：FDA检查的准备和管理.ppt

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FDA Inspection Preparation and Management：FDA检查的准备和管理

FDA Inspection Preparation and Management Massachusetts Biotechnology Council April 28, 2009 David L. Chesney, Vice President Strategic Compliance Services PAREXEL Consulting Dave.chesney@ 978-848-2256 Basics for FDA Inspection Preparation and Management Understand and respect FDA’s inspection authority Be familiar with FDA Compliance Programs applicable to your industry sector Develop a company inspection management SOP Train staff so that they understand the process and can follow the SOP Emphasize the need for staff to be truthful and professional in their interactions with FDA Control the environment Communicate clearly during and after the inspection General Caution This will be a rather quick summary of the key considerations in managing inspections. An in depth study and careful preparation on your part is needed. FDA inspections carry legal risk for the company and individuals For this reason, it is wise to include legal counsel in key decisions surrounding the management of FDA inspections The guidance in this presentation is intended to help inform you about some of the issues FDA inspections present, but is not intended to be legal advice, nor to include every aspect that companies should consider in their inspection preparation. Seek the guidance of counsel when finalizing inspection policy and procedure to ensure it is legally sound and properly crafted to protect the company in this important area. FDA Inspection Authority Section 704 of the Federal Food, Drug and Cosmetic Act (drugs and devices) – we will abbreviate as the “FFDCA” Section 351(c) of the Public Health Service Act (licensed biologics) and 361 (tissue products) 21 CFR 600.22 (licensed biologics) 21 CFR 1270 (tissue products) As a practical matter, 704 of the FFDCA is the governing law FDA Inspection Authority Section 704, FFDCA: “Enter and inspect” At reasonable times, within reasonable limits, and in a reasonable manner For Rx drugs (including biologic drugs), “…inspection shall e