Managing and Responding to FDA Inspections

Title:Managing and Responding to FDA Inspections

Volume: 2 Issue: 1

Author(s): Susan Margaret Muhr Leister

Affiliation:

Keywords: Audits, bioresearch monitoring program (BIMO), FDA (Food and Drug Administration), inspection readiness, quality management systems, regulatory inspections.

Abstract: Is your facility inspection ready at all times? Most organization are not ready at all times and, therefore find preparing for any type of FDA Inspection to be overwhelming. This paper provides guidance on how to prepare and how to respond to the FDA, specifically for larger clinical site inspections, Clinical Investigators, and drug manufacturer inspections. Also, tips are provided on how to take a proactive inspection readiness approach. These same inspection readiness strategies can be applied in a reduced manner by smaller organizations to help successfully manage regulatory inspections.

Cite this article as:

Muhr Leister Susan Margaret, Managing and Responding to FDA Inspections, Applied Clinical Research, Clinical Trials and Regulatory Affairs 2015; 2 (1) . https://dx.doi.org/10.2174/2213476X02666150903203830

DOI https://dx.doi.org/10.2174/2213476X02666150903203830	Print ISSN 2213-476X
Publisher Name Bentham Science Publisher	Online ISSN 2213-4778