Validation and Change Control Basics

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	Overview		An introduction to the principles of validation and how they are applied to computer systems, processes, cleaning, and QC methods. Also emphasized is change control and its connection to validation.
	Objectives		Define and describe important terms related to qualification and validation Discuss the history and importance of validation Describe how three different types of validations are conducted Describe the importance of change control Identify items that must be evaluated when considering a potential change Discuss risk assessment in terms of change control Given a situation, discuss how change control should be applied
	Instructional Methods		Presentation, small group activities, and discussion.
	Primary Audience		Product development, Regulatory Affairs, Quality Assurance, and Quality Control personnel.
	Length		4 hours