Current Class Dates (subject to change):

Scheduled as Needed based on Student Demand.  Email us at onlinetrain@nortonaudits.com if you are interested in this course.

Description - Receive expert training from an award-winning former FDA investigator on implementing Institutional Review Board (IRB) regulations when performing assessments on the behalf of sponsors and Contract Research Organizations. Participants will learn how the FDA conducts Quality Systems Audits of IRBs, increase writing and case development skills and leave this program with a clear understanding of the Title 21 and Title 45 Code of Federal Regulations. 
                                                                                           
Class Agenda/Modules -                                  Instructors Make a Difference

• Laws Governing IRB Operations
• IRB Global Quality Systems
• Auditing and Assessment Tools and Techniques
• IRB Standard Operating Procedures
• Writing Skills and Case Development

Typical Class Attendee -

• Sponsor Auditors
• Contract Research Organization Auditors
• Institutional Review Board Internal Auditors
• Food and Drug Administration Investigators
• Independent Consultant Auditors
• Compliance Auditors

Auditing Level - Advanced; Auditor position for five years, preferably with a four-year medical or science degree

Class Price - $1500 (20% Southeast Regional Discount and 10% multiple persons  from the same organization discounts are available)