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Institution:
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Bergen Community College
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Subject:
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Description:
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This course is designed to develop the students' ability to appreciate the significance of documentation in assuring product integrity. The student will learn to write basic procedures that conform to regulatory guidelines and to critique existing documentation for adequacy. The course will consist of taking a process such as the manufacture of a solution, and using Excel to develop the documentation required for product development, manufacture, safety, quality control, and non-conformance. Procedures will be peer evaluated in the laboratory for ease of comprehension and implementation and for adherence to industry safety and quality standards. Student SOPs will be approved and filed in accordance with FDA guidelines. Lecture [3.00], Laboratory [3.00].
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Credits:
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4.00
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Credit Hours:
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Prerequisites:
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Prerequisite[s]: TEC-145.
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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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(201) 447-7200
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Regional Accreditation:
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Middle States Association of Colleges and Schools
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Calendar System:
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Semester
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