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Recorded CD Only: $275
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An Audio Conference
Training Class
Held November 17, 2007
Recorded CD Available
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 seven global skills to be an effective auditor or monitor. This program will (1)
increase legal expertise for understanding key regulations, (2) provide auditing
organizational skills, (3) implement a proper reporting structure and procedures from auditing or
monitoring observations, (4)examine key case studies to examine how to apply key skills
presented, (5) increase knowledge for observations and inspections of clinical investigator’s
facilities, (6) present auditing interviewing skills and (7) data auditing techniques. Skillls,
techniques, and tips will be presented for the auditor or monitor to use immediately.
Slides will be provided via email to each Site prior to the class
for printing.
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