Unfortunately, I couldn’t find a specific website dedicated solely to the topic of “Reality in Mock Inspections.” However, there are numerous valuable online resources that discuss best practices and the benefits of conducting realistic mock inspections across various industries.

To help you find the information you need, I recommend searching for the following terms online:

• “Realistic mock inspections best practices”
• “Simulating real inspections for effective audits”
• “Benefits of realistic mock audits and inspections”
• “How to conduct realistic mock [your industry] inspections” (e.g., “How to conduct realistic mock FDA inspections”)
• “Virtual reality for mock inspections and training” (if you’re interested in VR applications)

  Mock audits should be conducted as early in development as possible; the end of the process is not the time for the first mock audit. From the beginning of the clinical process, a sponsor should conduct mock audits of its clinical suppliers. In addition, mock audits should also be done on an annual basis during the manufacturing process.

  The mock auditor should behave like an FDA investigator. Asking the mock auditor to show up unannounced is a way to realistically gauge how the staff executes their responsibilities while interacting with a regulatory agency inspector.

  FDA reviews a myriad of processes/systems during an inspection; identifying areas that require revision in advance of an actual inspection is time well spent. This exercise also provides staff an opportunity to clarify requests for information, identify areas that need to be addressed, or discuss observed gaps in information or processes being evaluated.

  FDA does not cut corners and, therefore, neither should a sponsor. In order to get the most out of the mock audit, it is essential that the audit is conducted as thoroughly as possible and should follow the same process as an FDA audit.