Basics of Auditing for Regulators
Last Update: July 30, 2007
This is an introductory course designed to prepare FDA investigators, state, local and tribal inspectors, regulators, program managers and supervisors for various applications of auditing. The course will emphasize principles such as observing performance, comparing performance to criteria, and evaluating/assessing performance.
After completing the course the regulator should be able to:
Resources for Audit Procedures and Forms
FDA Employees use the following link;
State, Local and Tribal Regulators use the following link;
These links provide all forms and procedures documents for ORA’s Certification programs. The documents address performance audits conducted as the final step to achieving Level I and Level II certification in ongoing ORA certification programs.
If you are required to complete this course and must have an official record of completion, you must log on to ORAU's ComplianceWire, complete the exam and electronically sign that you completed the course.
If you are a first time user and you do not have a ComplianceWire login ID, follow the First Time User Login Instructions.
ORAU Values Your Opinion
After you complete this course, please take a few minutes to complete an ORAU web-based course evaluation --- You may print this form, complete it, and fax it to DHRD at 301-827-8708, Attn: Beverly Green.