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  1. Office of Training Education and Development (OTED)

Basics of Auditing for Regulators

Basics of Auditing for Regulators

Course Description

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.

Training Objectives

After completing the course the regulator should be able to:

  1. Recognize why performance oversight of the regulatory process/function is important
  2. Identify how to improve his/her assessment of others
  3. Identify the skills required of performance auditors
  4. Recognize the differences between assessing inpiduals and programs
  5. Recognize the need to avoid influencing the outcome of an inspection
  6. It is a copy/paste task.

Resources for Audit Procedures and Forms

FDA Employees: Use the FDA Intranet to find resources.

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.

  • After logging in, select Knowledge Finder
  • Search for Basics of Auditing for Regulators
  • Select Control Document

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.

Launch the course

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