BIOT 2320 - Regulatory Affairs and QC Lab Skills

Institution:

Minneapolis Community and Technical College

Subject:

Description:

4.00 credits (4.00 lec) This course will provide an overview of the regulations that govern the bioscience industry and incorporates handson laboratory experiences. Students will learn extensively about Food and Drug Administration (FDA) regulations with a focus on Current Good Manufacturing Practices (CGMPs) including Quality Control (QC). They will gain a basic knowledge of Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Tissue Practices (GTP) and the approval processes of bioscience products. Students will appreciate the importance of international regulations, intellectual property, and import and export considerations. The laboratory sessions will provide hands-on experience in QC procedures, safety regulations, routine lab maintenance aspects, aseptic techniques and clean-room procedures. Students will practice good record-keeping and critical documentation aspects and learn about Standard Operating Procedures (SOPs). They will also perform various scientific measurements and adopt the associated mathematical calculations; prepare various laboratory reagents, and learn accurate pipetting techniques and sterilization procedures; and handle basic instrumentation widely used in academic and industry laboratories at entry-level positions. Prerequisites: CHEM 1151. Prerequisities/Corequisites: BIOT 1000 and all prerequisites for these courses apply.

Credits:

4.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.minneapolis.edu

Phone Number:

(612) 659-6000

Regional Accreditation:

North Central Association of Colleges and Schools

Calendar System:

Semester

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