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.

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Learning Objectives

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• 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.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.