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 - This skill-based training program is taught by personnel with more than 15 years of field experience and teaches the skills and techniques utilized during U.S. FDA and client audits. The course has a two-fold focus: on organizing, participating in and conducting external regulatory and client audits; and on the current FDA Bioresearch Monitoring Programs. Attendees will prepare an audit plan and complete an auditing standard operating procedure. 
                                                                                           
Class Agenda/Modules -                                  Instructors Make a Difference

• FDA’s Bioresearch Monitoring Programs
• Planning, Organization and Participation
• Corrective and Preventative Actions (CAPA)
• FDA and Client Audits Standard Operating Procedures
• Common Audit Findings and Responding to Observations

Typical Class Attendee -

• Sponsor Auditors
• Contract Research Organization Auditors
• Clinical Investigators
• Clinical Research Associates and Coordinators
• Institutional Review Board Internal Auditors
• Independent Consultants
• Compliance Auditors

Experience Level -Intermediate; research position for one year

Class Price - $875 (20% Southeast Regional Discount and 10% multiple persons  from the same organization discounts are available)