Title: How can the Medical Device Industry Stay Prepared with Respect to FDA Expectations?
Course: PW-Course-Import-Test > Section: Module 7: Internal Audit Programs

Module 7

In module one we covered the potential consequences of non-compliance to the regulations.

As a licensed (e.g. 510(k) approved) participant in the medical device industry, the company “owns” the obligation to comply with the regulations. The regulation requires Industry to monitor compliance to the regulation in accordance with 21 CFR 820.22.

Industry is required to internally review and monitor compliance to the regulations and take appropriate steps to correct any non-conformances.

If QSR non-conformances are detected during an FDA inspection - the firm under investigation should expect that the FDA will review compliance to 21 CFR 820.22 (e.g. the firm’s Internal Audit program) to see if a weakness exists in this QSR sub-system that prevented the firm from discovering the non-compliance BEFORE the FDA did.

If the FDA observes a weakness in a firm’s ability to detect compliance deficiencies internally, they will certainly follow additional inspection threads and frequently move towards issuing a citation if a series (e.g. systemic) of issues are discovered.

Note: Internal audit observations, audit notes, results and corrective actions from the firm’s internal audit program are specifically excluded from FDA review. Read the Preamble comments starting with comment #53 to find out why.

Read

Read 21 CFR 820.22 and Preamble for comments related to Internal Audits.

Watch

Watch "Internal Audit Slide Deck" that describes audit types including external (FDA audit) preparation.

At the conclusion of the Slide Deck presentation there are several case studies that can be viewed through links that are provided. The links will take you to actual 483 inspection findings that will allow you the opportunity to practice the concepts of internal auditing and FDA inspectional observations by virtue of a review of these documents. Further explanation is provided starting with slide 16 in this Slide Deck.