This web based training module focuses on Inspection Readiness to ensure your organization is prepared for inspections every day. Your personnel will understand the history of inspections, be ready to participate in an inspection, and know the roles and responsibilities for the inspection team. This three-module course teaches how to prepare for an inspection, what to expect during an inspection, how to manage and inspection and the roles and responsibilities during an inspection. The modules can be assigned independently to different personnel in your organization based on their involvement with inspections.
Module One: Inspection Overview This module details the history of inspections for the FDA, expectations during an FDA inspection, and identification of the players in the FDA inspection.
Module Two: Preparation This module focuses on preparing for the inspection and the key roles in your inspection readiness team.
Module Three: Execution This module focuses on how to execute the inspection, the meetings held during the inspection process and the next steps after an inspection.
Successful FDA Inspections: Essential Preparation and Management Tools - What Regulators Expect and How to Prepare (June 13-14, 2023)
- 2 Days