cGMP Basics - This workshop takes look at FDA and its cGMP regulations

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cGMP Basics

	Overview		A look at the history and background of the U.S. Food and Drug Administration (FDA) and its Current Good Manufacturing Practice regulations. The five values found in the cGMPs (safety, identify, strength, purity, and quality) are defined and examined. Individual and group exercises provide learners a chance to discover what they do in their jobs to assure the cGMP values are maintained. Can also show similarities between the cGMPs and the GMP requirements of other countries.
	Objectives		Identify the regulations that cover the manufacture and control of drug products Describe why the FDA regulates the drug industry in the U.S. Identify and define the five GMP values Identify what you could do on your job that supports the GMP values Discuss what could happen if one did not follow the values and the GMP regulations Identify what you will do to personally improve your meeting GMP requirements
	Instructional Methods		Presentation with visuals, individual exercises and small and large group discussions.
	Primary Audience		Operational, technical, supervisory, and management personnel with little or no training in cGMPs.
	Length		3.5 hours.