Behavior in Inspections

In general, the selection of persons who have direct contact with the FDA inspectors should consider that the following skills are well developed balanced mood. 

For the dress code, there is only one rule You should feel comfortable in your clothes. Not too formal - not too casual, but comfortable and customary clothes that do not overly exceed the level of the inspectors clothes. If you generally do not wear a neck-tie, you should not wear it in the inspection. Women shoirld avoid shoes with very high heels and use decorative cosmetics, accessories and jewelry with restraint. 

The inspectors are usually addressed by first-name, if he or she does not present and behave in a very formal way. This is common in the United States and, however, should not be interpreted as a chummy form of address (as it may imply for Europeans). It should be remembered that the inspection is a formal administrative act, similar to a tax audit or judicial investigation, despite the relaxed and casual appearance, or speech of the inspectors. Monitor the situation thoughtful and focused, and try to help the inspector to make his or her work as comfortable as possible. The general behavior shoirld be characterized by friendliness and commitment, because people from the American culture are accustomed to a friendly and open environment. A natural smile or friendly gesture is the best guarantee that you will reach the human touch of the inspectors. 

The form of address of your managers, colleagues, and subordinate employees should be retained, as it is customary in your company and in the individual relations If you generally address by first-name, you should also do it in the inspection and the same when you generally use the more formal surname. 

All inspection participants with direct FDA contact should be trained for the interaction with the inspectors, so that the chances of a successful communication increase. It has been proven in practice that it is helpful to observe the following points. 

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Case 8 Box Practical Tips on the Subject Behavior in Inspections... 

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