Title: Module 7 Conclusion
Course: PW-Course-Import-Test > Section: Module 7: Internal Audit Programs

Module 7

In this module we explored the requirements for 21 CFR 820.22 Internal Audits. We explored several examples of how an internal audit program can be implemented and executed. We explored how to conduct internal audits and also prepare for audits that are conducted by third parties.

We learned about developmental opportunities for those who would like to pursue Internal Auditing as a career choice. We explored the FDA inspectional observation database to see how this tool can help develop audit plans.

Study these Take Away Notes for a review of the main points of this module. You can think of it as a study guide for your assessments.

At this point we have covered all of the basic requirements of the regulation including how to internally audit to maintain a state of compliance.

Coming Up...

The last and final module will explore ISO 13485. This standard is similar to 21 CFR 820 but is not recognized as an equivalent regulation. This standard is recognized internationally. This standard is relevant for medical device companies that market internationally.