FDA Bioresearch Monitoring Inspections are the FDA’s actions to ensure the protection of the rights, safety, and welfare of human research subjects involved in FDA-regulated clinical studies. Although essential these inspections can be daunting, this session will provide insights into FDA Clinical Investigators and Sponsor-Investigators' Inspections for Bioresearch. The session will focus on FDA processes and procedures for inspections, experiences from panelists who have been involved in site inspections themselves, and exploration of methods to best prepare for future FDA Inspections at your clinical research site.