FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect

By understanding the process and how to address inspectional findings, your involvement in a Food and Drug Administration (FDA) clinical investigator inspection may transform into a less stressful and more positive experience.

Join this webinar for an overview of the clinical investigator inspection process and what to expect, with insights straight from a former FDA Branch Chief.

Learning Objectives:

Identify the types of clinical investigator inspections: routine and for-cause
Understand what information will be evaluated and considered during the inspection process
Summarize best practices for addressing inspectional findings during and after an inspection

Presented By

Constance Cullity

MD, MPH

Senior Director, Regulatory Compliance
Advarra

Moderated By

Michele Russell-Einhorn

Former Chief Compliance Officer and Institutional Official
Advarra

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Who should watch?

This content applies to principal investigators; sponsors and sponsor-investigators; regulatory affairs representatives; research operations personnel; and others involved in research compliance from sponsors, CROs, and investigative sites.

CE Credits

Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations.

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.