LearningPlus Workshops: Documentation Systems and Practices

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Documentation Systems and Practices

	Overview		A workshop that describes the process of controlling, generating, reviewing, approving, distributing, and maintaining functional documents (SOPs, master records, lab methods, etc.) as well as records and reports.
	Objectives		Identify and describe the six major activities and elements in a GMP-compliant documentation system Discuss regulatory requirements and expectations for a documentation system Define and provide examples of functional documents Discuss how functional documents are produced so they can be effectively used Define records and the nine characteristics of a properly-prepared record Describe how electronic systems can be used in a documentation system
	Instructional Methods		Presentation, case study, small group activities, and discussion.
	Primary Audience		Those involved in QA, supervision, and document control.
	Length		Two to three days.