Regulatory Agency Inspections

This SOP explains how to prepare for and describes procedures to be followed by personnel who are involved in a FDA regulatory inspection. Front and back room operation is explained. Procedure explains best practices to create a written response to 483 observations received. SOP is based on personal experiences with FDA audits. A 3 page checklist for inspection preparation is included(13 pages +1 form)
Webinar slides are included which explain the SOP in detail and the context of the SOP. These slides could be used for training.