Title: Module 6 Conclusion
Course: PW-Course-Import-Test > Section: Module 6: Quality Records

Module 6

In this module we explored the requirements for Quality Records. We explored the specific requirements for DMR, DHR and Complaint Files. We researched the FDA database to see the frequency and type of citations that are issued for non-compliance to the regulations.

Coming Up...

In module 7 we will explore the requirements for 21 CFR 820.22 Internal Audits. A successful internal audit program is essential as an internal tool/detection mechanism to help medical device companies remain compliant.

This specific section of the regulation has been saved for module 7 in order to complete an overall exploration of the entire regulation before talking about the importance of internal audits. The internal audit program should cover all aspects of the quality system, although the frequency and type of audits that are conducted can be risk-based.