BIO 221 - Regulatory Affairs Compliance in Biotechnology

Institution:

Athens Technical College

Subject:

Description:

Banner Title: Regulatory Affairs Compliance This course is an introduction to regulatory agencies and the role of cGMP compliance in manufacturing of drugs, biologics and medical devices. The course initially explores the role of governmental oversight and regulation, particularly by the FDA, during the discovery, development and manufacturing of new products produced by the pharmaceutical and biotechnological industries. Benchmark Congressional Acts (e.g. the Food, Drug and Cosmetic Act) are studied while describing the evolution of the FDA to its present state. Case studies are emphasized. Students are introduced to facilities and processes used in the manufacture and packaging of pharmaceuticals (drugs and biologics) and medical devices. Thus studied are facility design, monitoring systems, cleaning and sterilization, clean room environments, and fill and packaging operations. The course emphasizes how good documentation practices assure the quality and safety of a product as the manufacturing process moves a product down the production pipeline. Prerequisite: Program admission Offered on an as-needed basis for the associate degree program in Biopharmaceutical Manufacturing Technology and the Quality Assurance and Validation Technician technical certificate of credit

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Multiple

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.athenstech.edu/

Phone Number:

(706) 355-5000

Regional Accreditation:

Southern Association of Colleges and Schools

Calendar System:

Semester

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