North Central Florida Chapter: FDA Audit Preparedness

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Speaker Name:
Anna Kukulka, RN, BSN, M.Ed., CCRC 
Training and Education Coordinator
UF Health Cancer Center, Clinical Research Office

Target Audience
CRCs
CRAs
Investigators
Auditors
Project Managers
Regulatory Affairs/Compliance
Data Managers (Site, Sponsor, CRO)
Quality Assurance
Clinical Research Administrators

Program Description
This program is intended to provide an overview of the FDA BIMO program, as well as provide instructions and guidance to clinical research staff for how to successfully prepare for and navigate an FDA Site Inspection.

Program Agenda
1155 - 1200: Sign-In and Registration 
1200 - 1250: Presentation 
1250 - 1300: Question and Answer Session

Learning Objectives
Identify appropriate contacts and resources in the event of an FDA Inspection 
Identify the steps required to prepare for an FDA Inspection 
Outline the process of an FDA Inspection 
List the characteristics of a study “at higher risk” for FDA audit