Title: What are the Benefits of Conducting Internal Audits?
Course: PW-Course-Import-Test > Section: Module 7: Internal Audit Programs

Module 7

The benefits of an effective internal audit program include, but are not limited to, the establishment of firm’s regulatory compliance to the law and potential avoidance of FDA enforcement actions.

Read

Read Warning Letter, an example of a deficient Internal Audit program. Note the FDA observations related to this company’s internal audit program.

How do you develop an Internal Audit Program / Process?

If you have not been exposed to what an internal audit program may look like - here is an ISO 9001 Internal Audit example. This example/format is generally acceptable as a starting point for a 21 CFR compliant Internal Audit Program.

How do you prepare yourself or others in the company to participate in an effective Internal Audit Program?

If you are interested in pursuing Quality Auditing as a career, the American Society of Quality (ASQ) offers personal/career development including but not limited to the areas of Quality Systems and Internal Audit.

Quality Auditor Certification - CQA - Is it right for you? describes one of the ASQ certifications related to Internal Audits.

Let’s test our knowledge to see what we have learned so far.