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An Audio Conference
Training Class
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 Program covers Expert Legal
Training on GCP and ICH to be an effective Auditor or Monitor. Learn the regulations from an
applied viewpoint for proper use in auditing or monitoring reports. Learn the FDA’s coding system
for investigator’s citations. Increasing your legal expertise is key to helping Investigator’s and
their study teams to comply under their obligations. Examination of the most commonly cited
regulations will be evaluated. Regulation ‘theme-based learning techniques’ will be used to help
the participant organize their regulation knowledge for expert application.
Slides will be provided via email to each Site prior to the class
for printing.
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