Tamera Norton Smith, Ph.D, MT(ASCP) is President and Senior Consultant for Norton Audits, Inc. She has twenty 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.