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Recorded CD: $275
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An Audio Conference
Training Class
Held August 3, 2007
Recorded CD Available
Live Class Again in 2008
Target Audience:
Clinical Research Auditors, Monitors, Coordinators, Investigators, Data and
Project Managers
Instructor:
This program is taught by
Tamera Norton Smith, Ph.D., MT(ASCP)
President and Senior Consultant for Norton Audits, Inc. She has seventeen years of U.S. Food and Drug
Administration and Clinical Research pharmaceutical, medical device, and biotechnology experience. As a former U.S. Food and Drug Administration
Investigator, she won several awards for casework related to Good Clinical Practices, Good
Manufacturing Practices, Biologics, and Fraud Detection. As a major US Sponsor Senior Clinical Research
Associate she monitored world-wide trials and developed training programs in fraud detection and
monitoring processes in general. Ms. Smith founded Norton Audits, Inc. in 1999 and is
currently an active auditor, author, consultant, national speaker, and trainer throughout the
pharmaceutical, medical device and biotechnology industries.
Class Description:
This Norton Methods Skill-Based Auditing Techniques Program
covers The Detection and Prevention of Clinical Research Misconduct and Fraud. The program defines
the legal definitions of noncompliance, scientific misconduct and fraud. Case studies will be
examined to evaluate lessons learned from known misconduct cases. Skills, techniques, and tips will
be presented for the auditor or monitor to use immediately. Skills will be covered for objectively
evaluating and determining the difference between noncompliance and misconduct.
Slides will be provided via email to each Site prior to the class
for printing.
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