BTCP 105 - Good Manufacturing Practices & Quality Issues

Institution:

Raritan Valley Community College

Subject:

Description:

Prerequisite: ENGL 111 - English I. Good Manufacturing Practices and Quality Issues is a course that will expose students to the regulations and guidelines that Pharmaceutical/Biotechnology/Medical Device companies are required to follow and comply. 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 will also emphasize aseptic processing and related aspects of product quality.

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

The Course Profile information is provided and updated by third parties including the respective institutions. While the institutions are able to update their information at any time, the information is not independently validated, and no party associated with this website can accept responsibility for its accuracy.