BIOT 103 - Safety and Regulatory Compliance for Biotechnology

Institution:

Ivy Tech Community College-Central Office

Subject:

Biotechnology

Description:

Overview of laboratory safety procedures and precautions, biosafety, radiation safety, compliance standards of regulatory agencies. Emphasis will be placed on understanding the regulatory environment of pharmaceutical, diagnostic and agricultural research and manufacturing. Students will be introduced to the agencies in the U.S. responsible for regulatory oversight of biotechnology. Concepts of current good laboratory practices (cGLP), current good manufacturing practices (cGMP), standard operating procedures (SOP) and validation will be addressed as they apply to industry.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

Phone Number:

Regional Accreditation:

North Central Association of Colleges and Schools

Calendar System:

Unaccounted for code

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