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Certificate in Biochemistry & Biotechnology Industry - Intro to Working in a Regulated Biochemistry and Biotechnology Industry

Course Code
BCBT 420  Credits
Title Intro to Working in a Regulated Biochemistry and Biotechnology Industry 
Prerequisite BCBT 200 
Course Outline Course Outline 
Description This course will cover the basic structure of the regulated workplace; introduction to regulatory affairs, introduction to regulatory language: FDA and USDA; an overview of good practices: good laboratory practices (GLP), good manufacturing practices (GMP) and good clinical practices (GCP); introduction to quality systems: quality control, quality assurance, ISO9000, and six sigma; introduction to validation. Student must be in junior standing in a bioscience or chemistry major.