| After you have defined the educational programs and | | | | thorough review of the lessons learned after it is |
| standard operating procedures (SOPs) for | | | | finished. |
| government inspections, it is wise to choose several | | | | The review process has to include: |
| studies to apply to a mock audit. | | | | -Comments from the mock inspector in regards to |
| You can base your selection on the criteria | | | | what was done well and what needs improvement. |
| established by the FDA and on the type of work | | | | -Observations from the QA team and others who |
| your company does; for example, a good option | | | | witnessed the activity. |
| would be a crucial Phase 3 study that was recently | | | | -Input from the participants about what happened |
| completed and includes a good number of subjects, | | | | during the audit and about the value of the activity. |
| and it is also important to consider the accessibility of | | | | -The creation of an action plan to take care of |
| the data and the staff that will participate in a | | | | compliance issues and organizational deficiencies that |
| specific study. | | | | surfaced during the exercise. |
| First, choose a location and a study, and later | | | | -A follow-up report to make sure the action plan is |
| develop a plan for your mock audit based on your | | | | put into practice. |
| SOPs and on the right FDA compliance program | | | | Take advantage of the debriefing process to ask the |
| manual. | | | | participants about any negative feelings that came up |
| This plan should clearly state: | | | | during the mock audit. A mock inspection may upset |
| -The audit's goals | | | | people, make them feel they were treated unfairly |
| -The project and location you chose | | | | or criticized, or that the issues uncovered could be |
| -The participants | | | | held against them. |
| -The time frames for completing the audit | | | | Managers and executives who participated must |
| Be very diligent when addressing the requests for | | | | make sure everyone understands that the results will |
| information that the mock inspector will issue, taking | | | | not affect anyone's job; otherwise, future mock |
| into account the significant questions about regulatory | | | | audits will lose effectiveness due to employee fear. |
| knowledge, data validation, observance of SOPs, and | | | | Mock audits must be a regular practice of any |
| compliance documentation. | | | | pharmaceutical company's training program; thus, it |
| Even more so, include an educational program into | | | | requires full management support and staff |
| the mock audit process. Define how and when the | | | | participation. |
| participants will be "debriefed", and how you will | | | | Pharmaceutical consultants believe that when these |
| follow up on the lessons learned from the exercise. | | | | exercises are held at regular intervals, more and more |
| Once you start the mock audit, make it as real as | | | | people share the learning experience, and the |
| possible. Follow a clear plan and treat the mock | | | | company can regularly improve its level to face real |
| inspector exactly as you would treat the real one. | | | | audits as well as its operational systems. |
| Everyone must remain "in character" throughout the | | | | If you liked this article, tell all your friends about it. |
| whole process to get the best out of the activity. | | | | They'll thank you for it. If you have a blog or |
| It can be educational to invite managers, executives, | | | | website, you can link to it or even post it to your |
| and members of other projects to observe the | | | | own site (don't forget to mention our Pharmaceutical |
| mock audit; and it is because of the educational | | | | Consultancy blog as the original source). |
| aspect that the mock audit requires immediate and | | | | |