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First Annual Auditing Forum A Success
10.13.2008
Expert Training, Panel Discussions, Case Studies and Techniques Presented
(More)
Norton Audits Increases International Auditing Experience
08.05.2008
Audits in Russia, Poland, Ukraine, Romania and Germany add to North American Expertise
(More)

Our Name


Formally incorporated in 2000, Norton Audits, Inc., abbreviated NAI, represents our commitment to helping your organization achieve ‘No Action Indicated’; a US Food and Drug Administration term for full compliance with regulatory requirements and an indication of minimal risk for protocol failure or patient safety in your clinical research activities.

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Our People

Clinical research experts that are grounded, trained and field-experienced in regulatory law and the real world application of industry compliance policies, procedures and activities. Some of our consultants are former award-winning FDA Investigators that are regulation experts providing proper interpretation and working knowledge of regulations.   All of our consultants have field experience in achieving protocol and regulation compliance for Sponsors, CROs, IRBs and Clinical Investigators.

Tamera Norton Smith, PhD, MT(ASCP)

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

 

Jeff Smith, BS, MBA

 

Jeff Smith, BS, MBA, is Vice President for Norton Audits, Inc. leading customer service, project management, marketing, and operations activities.  Jeff brings 18 years of project management experience from the clinical research, manufacturing and sales/marketing industry, along with extensive knowledge in software, customer service, and engineering.  In addition, he has experience in several regulated industries, including clinical research, from which a strong understanding of Quality Systems and Proactive Processes has been developed. 

 

James Robinson, BS

 

James Robinson, BS, is a Senior Auditor and Consultant for Norton Audits, Inc.  He has 28 years experience as an award-winning Senior Investigator for the U.S. Food and Drug Administration, along with significant experience as an independent industry auditor.  Throughout his career with the FDA, he was awarded several Exceptional Performance Awards as well as awards for completing four high priority volatile BIMO Inspections in South Africa.  Mr. Robinson’s international and US-based experience in pharmaceutical, medical device and biotech therapeutic areas is extensive and includes OBGYN, Ophthalmology, Oncology, Dental, Diabetes, Infectious Disease, Gastrology, Pediatric, Dermatology, Osteoporosis, Cardiology, and Arthritis.

 

Melissa Pong, MS, CCRA

 

Melissa Pong, MS, CCRA, is an Auditor, Instructor, and GCP Specialist for Norton Audits, Inc.  She has over 14 years experience as a Clinical Research Associate, Research Lab Technician, and Consultant with several large pharmaceutical firms including Corus Pharma, Inc., ICOS Corporation, PAREXEL International, Abbott Laboratories, Rush Cancer Institute and IIT Research Institute.  Ms. Pong’s career achievements include managing and auditing several clinical trials in many therapeutic areas including Ophthalmology, Urology, Osteoarthritis, Oncology, Cardiovascular, Infectious Disease, OBGYN, Pain Management, and Respiratory.

 

Roberta Smith, AS

 

Roberta Smith, AS, is the Technical Writer for Norton Audits, Inc. bringing her 16 years of graphic art and communication skills to developing effective training programs for CRAs, Auditors, Coordinators, Investigators, and all Clinical Research Professionals.  Combined with the over 50 years of research experience within Norton Audits, Ms. Smith creates graphic, audio, and text-based training materials that are deployed in on-line web-based training programs, manuals, and live training class materials.  Ms. Smith also oversees the processing of customer orders for customized Standard Operating Procedures for Investigators, CROs, IRBs, and Sponsors.


 
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