Fundamentals of FDA Audit Preparation
Earn contact hours upon successful completion!
FDA Audits
Why Will the FDA Choose Your Site for an Audit?
What are the Issues on Which FDA Auditors Will Focus?
What Does the FDA Tell Their Auditors?
How Do You Prepare?
What Should You Do During an Audit?
When Will an Auditor Write a 483?
Can You Prevent a 483 From Progressing to a Warning Letter?
Review of Typical Warning Letters and How to Respond
Practical Advice on How to Avoid the Most Common Mistakes
Review of the most common problems found from experience performing over 400 audits
Review of the federal regulations and ICH guidelines most often sited for non-compliance
Program Schedule and Location
Date: Available upon request
Time: 9:30am - 11:30am
Place: 1981 Marcus Avenue, Suite 210, Lake Success, NY 11042
Instructor
Michael Belotto, MPH, CCRA, CCRC
Cost
$300 per person
Contact Hours
This CE activity was approved by the New York State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation, and is assigned approval code 6S8NVB-PRV-06251. Upon successful completion of this program, each participant will be awarded 2.0 contact hours.
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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.
