Events

Event Title	NRP JUNE Education Session: FDA Observation Trends and UNC Common IND/IDE Audit Findings
Location	This session will be HYBRID. Location for in-person is 133 MacNider and the Zoom link will be included in the registration confirmation.
Sponsor	UNC Network for Research Professionals
Date/Time	06/17/2025

For more information, contact the event administrator: Paula Steele paula_steele@med.unc.edu

Event Presenters

Name	Title
Jamie Kauwell, MHA, CCRC, CHRC	Director, Clinical Trials Quality Assurance (CTQA)	Clinical Research Compliance Office
CTQA Office		Clinical Trials Quality Assurance Office

Session Status	Session	Session Date	Start Time	End Time	Cutoff
Expired	IN PERSON, LUNCH PROVIDED: FDA Observation Trends and UNC Common IND/IDE Audit Findings	06/17/2025	12:00 PM	1:00 PM	none
Expired	VIRTUAL : FDA Observation Trends and UNC Common IND/IDE Audit Findings	06/17/2025	12:00 PM	1:00 PM	none

NRP JUNE 2025 Education Session: FDA Observation Trends and UNC Common IND/IDE Audit Findings

Objectives:

• Identify trends in FDA sponsor data.

• Recognize general sponsor responsibilities.

• Describe FDA 483 findings.

• Understand common findings noted during IND/IDE audits at UNC.

The session will be hybrid.

The in-person session will take place in 133 MacNider, and lunch will be provided to registered in-person attendees. The room will be available until 1:30, so this is a great opportunity to network with colleagues after the presentation.
Virtual : Zoom link is included in the registration confirmation for live virtual viewing.

** If you need to change your viewing option after registering but before the event date, you can update your registration on the event website. Simply go to "View My Registration", locate the session in your "Registered List", click "Edit" on the far right, and switch to your preferred session.