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Products Custom
Solutions here
Inspection
Preparation 
Situation |
The Canadian site of a multinational firm was expecting a series of regulatory inspections from the Canadian Health Protection Branch and the U.S. Food and Drug Administration. Their facility was prepared, but personnel at all levels were quite nervous. Many of them had never participated in an inspection. |
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LearningPlus
Response |
In addition to using LearningPlus courseware (Preparing for a Regulatory Inspection), LearningPlus developed an intensive three-part workshop where management and subject matter experts could face past FDA and HPB inspectors. The inspectors and a communications expert provided feedback at the end of each interview. Each interviewee could evaluate his or her own session via a videotape of each interview. | ||
Outcome |
Significant improvements were seen between the first and second interviews, primarily in the area of the interviewees providing information that was satisfying to the inspector. Several people were deemed to need additional coaching. Shortly after the workshops, the firm passed both HPB and FDA inspections. | ||
