Purchase the recording of a web seminar you have attended in the past and SAVE 50%! Contact Barnett Customer Service for details: +1 781.972.5400 or toll-free in the U.S. at 800.856.2556.
Web Seminar Archives provided through Barnett’s Learning Management System (Single User access) or by electronic file transfer (Site License).
Site license archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.
Bulk Archive access is available via Barnett’s Training Subscription. Click here to learn more.
Archive: Preparing Clinical Research Sites for FDA Inspections
Course Description
This web seminar is designed for participants that are sponsors/CROs and research site representatives preparing for a research site FDA inspection. From audit readiness to action item resolution, each site faces its own unique challenges. This course will prepare you and your site for expectations from the FDA and provide concrete steps you can take to prepare before, during and after the inspection.
Video Preview
Learning Objectives
- Recognize the anatomy of an audit: The foundation of preparation, the regulations and ICH, types and focus of FDA audits
- Review the dynamics of audit readiness: Starting at site selection, preparing sites with large deficiencies
- Discuss the mission of the FDA BIMO Program revisions
- Recognize the timing of an FDA audit: Audit readiness, action item resolution, follow up after the audit
- Identify mechanics of the audit: Start to finish
Who Should Attend
- Project Managers
- Clinical Research Associates
- Site Managers
- Research Site Personnel
Instructor
Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.
Click here for complete trainer biographies
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.
