GMP Training issues for QA Personnel

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GMP Training Issues for QA Personnel

	Overview		An overview of training expectations that auditors and FDA investigators have of pharmaceutical firms. Also included is an overview of the instructional systems model used to create and develop training courses.
	Objectives		Discuss the compliance and quality reasons for training Identify and discuss current expectations for training in a GMP facility Describe the five phases of the instructional systems design model and why it is used Given a situation, identify how it could be improved Describe current practices related to documentation, curricula design, training procedures, SOP training, and learner assessment
	Instructional Methods		Presentation, case study, small group activities, and discussion.
	Primary Audience		Quality assurance and regulatory affairs staff.
	Length		Half day.