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2009 Clinical Research Workshop

How to Build Quality into your Program for a Food and Drug Administration (FDA) Audit

Presented by Michael R. Hamrell, Ph.D., RAC - President of MORIAH Consultants

Location
Accreditation
Objectives

Tuesday, May 5, 2009

A record number of domestic and international FDA inspections and Office of Human Research Protection audits have resulted in an increased number of warnings to sponsors, principal investigators, and Institutional Review Board. Using case studies, simulations and actual finds, the 2009 Clinical Research Workshop will provide participants the opportunity to learn about the considerations for non-compliance, the types of regulatory concerns an audit can lead to, and detail how to approach clinical trials that comply with good clinical practice.

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Location

T. Boone Pickens Biomedical Building
UT Southwestern Medical Center
Room NG3.112
Dallas, Texas

For more information regarding the workshop, please call 214-456-1865 or email the workshop coordinator.

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Accreditation

This program has been approved by the American Association of Critical Care Nurses (AACN) for 6.5 contacthours, CERP category A, file number 00015061.

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Objectives

Understand how to prepare and respond to a FDA audit review and audit findings. Learn how to build quality into your clinical trials program.

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