Applying cGMP Regulations - Current Good Manufacturing Practice - GMP, cGMP, FDA regulations, Regulatory training

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Applying the cGMP Regulations

	Overview		A more specific training workshop on the cGMP requirements and expectations for particular areas and/or jobs. The cGMP regulations are divided into three categories: Resource-related Methods and materials-related Documentation and distribution-related Learners use Warning Letters and Form FDA-483s as case studies to determine what the problems were, their implications, and how the problem should be corrected. Small groups determine which sections of the cGMPs could be used as the basis for the observation, how the situation could be corrected, as well as the consumer / patient / organizational implications of the situation.
	Objectives		Identify three main categories of topics covered by the cGMPs Describe the relationship between parts, subparts, sections, and paragraphs of the cGMPs Discuss the impact of GMP violations on the patient and the manufacturer Given a violative situation with the FDA, describe how it could be corrected.
	Instructional Methods		Presentation with visuals, case studies, individual exercises, small and large group discussions.
	Primary Audience		Operational, technical, supervisory, and management personnel with a background and familiarity with cGMPs. Version available for operational and supervisory personnel. Applies to the pharmaceutical and biopharma manufacturing industries.
	Length		3 - 4.5 hours, depending on the number of cases used and amount of background information on cGMPs needed to be given at the beginning of the session. Version for operational personnel is 2 hours and uses 2 case studies.