BTCP 101 - Good Manufacturing Practices in the Pharmaceutical Industry

Institution:

Raritan Valley Community College

Subject:

Description:

Prerequisite: ENGL 111 - English I. Good Manufacturing Practices in the Pharmaceutical Industry is a course that will introduce students to the regulations and guidelines that Pharmaceutical/Biotechnology/Medical Device companies are required to follow and comply. The student will first learn how a company in the industry is structured, such as manufacturing, logistics, quality control, facilities, supplier quality, etc. Once the student is familiar with the company structure, they will be exposed to regulations defined in the Code of Federal regulations that each department must comply to. The students will get first hand experience in reviewing and writing Standard Operating Procedures, Work Instructions, and Batch Records. The students will be exposed to the significance of Validation Protocols for equipment, processes and test methods. Proper Documentation Practices required in a GMP regulated company and widely used terminology in the workforce will be covered and exercised throughout the entire course. This course is the first of three required for the Biotechnology Technician Certification.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.raritanval.edu

Phone Number:

(908) 526-1200

Regional Accreditation:

Middle States Association of Colleges and Schools

Calendar System:

Semester

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