After you have defined the educational programs and Standard Operating Procedures (SOPs) for state control, it is advisable to select several studies to apply for a mock examination. You can go your selection on the criteria of the FDA and the nature of the activity of your company, established customer base, such as a good option would be a pivotal Phase 3 trial, which has recently been completed, covering a wide range of issues and it is also important for the accessibility of data and the staff to consider participating in a specific study.

First, select a location and a study that later develop a plan for your mock exam based on your SOPs and on the right FDA Compliance Program Guide.

This plan should clearly:

The audit objectives
The project and location was chosen
The subscriber
-The time frame for the completion of the test

Be very careful in dealing with requests for information, the wrong question is Inspector, taking account of the serious legal questions about knowledge, data validation, compliance with the SOPs and compliance documentation.

Even more so, include an educational program in the mock audit process. Define how and when will the participants ‘debriefing’ and how will tie in with the experiences learned from the exercise.

After the start of the test mock, make it as real as possible. Follow a clear plan and treat the mock-treated exactly as the inspector real. Everyone must remain “get in character” throughout the process, the most of the activity.

It may ask for educational managers, executives and members of other projects, the observed mock exam, and it is learned because of the educational aspect, that the Mock exam requires immediate and thorough review of teaching, after it is finished.

The review must include:

Comments from the mock-inspector in terms of what did well and what needs improvement.

Observations from the QA team and others who witnessed the activity.

Input from participants about what happened during the trial and about the value of the activity.

-The creation of an action plan for the care of compliance issues and organizational deficiencies that appeared to take during the exercise.

ensure a follow-up report to that the action plan into practice.

Take advantage of asking the debriefing process, the subscribers of any negative feelings that came during the test Mock. A mock control may upset people so that they feel unfairly or criticized, were treated or exposed the problems that could be held against them.

Managers and executives, you need to ensure everyone understands that the results do not affect someone the task, otherwise future mock audits, the effectiveness of the employees fear of losing.

Mock Audits must be a regular practice of pharmaceutical companies, the training program so that it requires full management support and involvement of employees.

Pharmaceutical advisers believe that when these exercises held at regular intervals, more and more people share the learning experience, and the company can regularly improve its level of real face audits, and operational systems.

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