Fundamentals of GCP QA Auditing

One Day Program

Program Description

The Fundamentals of GCP/QA Auditing program is ideal for Clinical Quality Assurance Professionals and/or those wishing to know more about the "audit experience." This program will help prepare the student to audit clinical trials. Guidelines to detect, prevent scientific misconduct will be discussed.

Program Objectives

  • Identifying what auditors look for during a compliance audit
  • Understanding the purpose & components of Good Clinical Practice
  • Review of the Code of Regulations
  • Define Clinical Investigator’s responsibilities and their obligations to Sponsors
  • Describe informed consent in accordance with federal regulations

Program Schedule and Location:

Dates: July 16, 2010 (Friday)
          December 3, 2010 (Friday)
Time: 9:30am- 4:30pm
Place: 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042

Instructor

Michael Belotto, MPH, CCRC, CCRA


Cost

$800 per person

Refreshments

Breakfast, lunch and snacks will be provided for programs conducted at BRANY.

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Michael Belotto, MPH, CCRA, CCRC - Director, BRANY Institute of Research Education

Michael Belotto is the Director of the BRANY Institute of Research Education. He also serves as a research compliance expert responsible for auditing sites to ensure investigators and investigator staff compliance with ethical and clinical guidelines and FDA regulations. He serves on the BRANY Institutional Review Board.
Mr. Belotto was a paramedic in the New York City Emergency Medical Service for 10 years, with 7 years of experience in Hospital Administration.
Mr. Belotto is a graduate of New York Medical College where he completed a Masters in Public Health with a concentration in Epidemiology and Biostatistics.

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