Title: Learning Community: Internal Audits
Course: PW-Course-Import-Test > Section: Module 7: Internal Audit Programs

With respect to the ISO 9001 Internal Audit Example viewed earlier, please answer the following questions:

1. Think about Internal Audit requirements that should be identified in your local Internal Audit SOP. Review the ISO 9001 example and list two important elements/steps that must be part of the process.
2. Go to the FDA Inspectional Observation database. Sort all inspectional observations for the year 2015. Review the observations and develop a high level internal audit schedule that includes at least five elements of 21 CFR. Go to the learning community and list your five selections and indicate in what priority would you audit each of your elements. Provide a short rationale to justify your selections.