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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 Understanding
the FDA Inspectional Process of Clinical Investigators. The program is to provide skills to
Auditors, Monitors, Investigators and Coordinators to assist Investigators in FDA
Readiness procedures well before the FDA inspection. Learn a proactive compliance methodology for
inspections. The course will examine key warning signs during the inspection. We will examine
common mistakes made during the inspectional process. Techniques will be covered to respond to the
FDA upon issuance of the Form FDA 483. The most important lesson in this program is to learn how to
mange the inspectional process to prevent misunderstandings of the severity of issues discussed by
the FDA during the inspection.
Slides will be provided via email to each Site prior to the class
for printing.
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