FDA Audit Preparedness

HCR 565 Module 5: Exercise 3: FDA Audit Preparedness

You are the manager of a clinical research site, and were just informed that your site has been selected for a routine FDA audit in a week.
Please outline the steps your site and the sponsor should perform to ensure you are inspection ready. Include who at your center should be notified and why as well as who at the sponsor should be notified and why.
Please include the roles and responsibilities of each staff member involved in the preparation.
If there are other teachings to the staff that should occur prior to the inspection add those too as well as their relevance to the inspection.
Must be in a checklist format: responsible persons and task/activities. Please be thorough and ensure you cover all steps and departments.
Points 80
Format: 20 points
Roles and Responsibilities 40 points
Organization and relevance: 20 points

Pfeiffer, J and Wells, C (2017). A Practical Guide to Managing Clinical Trials. CRC Press. ISBN: 978-1-138-1965
Shah, K, Wells, C and Pfeiffer, J (2017). A Clinical Trial Workbook: Material to Complement Research Education and Training Programs. LAD Custom Publishing, Inc (Edition 2)
ISBN 978-0-8401-3527-8

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