LearningPlus Custom Solutions: Preparing for an FDA Visit / FDA inspection

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Preparing for an FDA Visit

	Situation		A biotech firm had an FDA inspection at one site that lasted much longer than it should have because associates unwittingly made inappropriate comments to the investigator. The firm wanted to make sure the next FDA audit went more smoothly.
	LearningPlus Response		LearningPlus prepared a one-hour workshop for all the firm's personnel including an overview of FDA inspections, proper and improper behaviors, and role-plays in which learners participated. Handouts provided participants "dos and don'ts" for future reference.
	Outcome		LearningPlus trained nearly 800 personnel in two months at all the firm's sites. While the firm awaits its next inspection, management and employees have commented they feel much better prepared and more confident.