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  1. Office of Training Education and Development (OTED)

Basics of Auditing for Regulators


MP150 - 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 assessment of others.
  3. Identify the skills required of performance auditors.
  4. Recognize the differences between assessing individuals and programs.
  5. Recognize the need to avoid influencing the outcome of an inspection/investigation.
  6. Complete and pass online exam.

Resources for Online Courses, Audit Procedures and Forms

For information on registration, other online courses, and certification program procedures and forms see links below:

If you are required to complete this MP150 course and must have an official record of completion, you must log on to ComplianceWire which can be accessed directly at www.compliancewire.com, 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


OTED Values Your Opinion

Please take a few minutes to provide your feedback regarding your satisfaction with the training, as it is critical to making course improvements.


Click the following link (or paste it into your web address bar):


Please remember to click “Submit” when finished.


  • No personal information is requested (e.g., name, birthdate), collected, or associated with results.
  • Participant information will be kept secure to the extent permitted by law.


If you have questions or need additional assistance in completing the evaluation, please send correspondence to ORAOTEDCertificationBasic@fda.hhs.gov.


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