BIO 340 - Biopharmaceutical Regulation

Institution:

Farmingdale State College

Subject:

Description:

This course introduces the student to Current Good Laboratory Practice (cGLP), Current Good Clinical Practice (cGCP), and Current Good Manufacturing Practice (cGMP) as defined in the Code of Federal Regulations Title 21. These regulations apply to all aspects of testing, clinical trials, and manufacturing of biopharmaceutical products under the authority of the Food and Drug Administration. The course will examine the application of these regulations to the bioprocessing, pharmaceutical, neutraceutical, cosmeceutical, and allied industries. Prerequisite(s): BIO 215 with a grade of C or better (3,0) 3 credits Contingent on demand

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

WWW.FARMINGDALE.EDU

Phone Number:

(516) 420-2000

Regional Accreditation:

Middle States Association of Colleges and Schools

Calendar System:

Semester

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