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Institution:
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Spokane Community College
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Subject:
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Description:
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This course explores the regulations which govern the production of drugs, biologics and devices for human use. This is of increasing importance in the biotechnology industry since the US Food and Drug Administration has generally required that products which are eventually used for human diagnostics or treatment must be developed in a GMP environment. Basic concepts of GMP are discussed as well as in-depth exploration of specific regulatory compliance topics such as record keeping, working from standard operating procedures, quality control and validation. (SCC)
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Credits:
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1.00
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Credit Hours:
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Prerequisites:
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Corequisites:
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Exclusions:
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Level:
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Instructional Type:
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Lecture
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Notes:
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Additional Information:
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Historical Version(s):
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Institution Website:
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Phone Number:
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(509) 533-8020
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Regional Accreditation:
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Northwest Commission on Colleges and Universities
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Calendar System:
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Quarter
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