Investigating Deviations

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	Overview		The FDA's expectations and best-of-industry practices are presented and linked to the firm's SOP on investigations.
	Objectives		List and describe seven steps used in investigating a GMP-related deviation Given a problem situation, identify specific actions that would best solve the problem Identify the goals and characteristics of a well-executed investigation List points to include in an investigation report Given an investigation report, identify and discuss its strengths and weaknesses
	Instructional Methods		Presentation, case study, small group activities, and discussion.
	Primary Audience		Manufacturing operations, support, and quality staff.
	Length		2 - 4 hours.