Auditing & Assessments

Mock Inspections are typically conducted with former FDA investigators. They bring real-life experience to what the company can expect during an FDA inspection. This experience has been proven to be invaluable to companies that have never been inspected and/or are planning for an upcoming inspection. It helps personnel understand the inspection process, what inspectors look for, and the techniques they utilize during the inspection. It provides firsthand experience of what the regulatory inspection will be like and helps personnel be prepared to respond to an inspector’s questions. As a result, the mock inspection identifies areas that need to be bolstered prior to a regulatory inspection. 

Mock inspections can also be performed either using a hats on / hats off model or in a direct mode, where our consultants remain in investigator mode for the duration of the exercise. Often, mock inspections include additional open Q&A sessions following the conclusion of the exercise to provide employees with additional learning opportunities.

Our experts can also help companies prepare for inspections of regulatory authorities by providing inspection readiness/preparation. We can teach companies how to manage inspections, including what documentation should be readily available, how to prepare Subject Matter Experts (SMEs), and how to take notes and record events. We often combine PAI Inspection Readiness training with mock audits. Find out more here.