TransfermaticBIOTECH at East Los Angeles College

    BIOTECH 103 - Quality Control and Regulatory Compliance in Bioscience

    Recent Professors
    Not yet assigned
    Recent Semesters
    No scheduled sections on record
    Class Size
    Not published
    Credits
    2
    Prerequisite
    Biotechnology 100.
    Transfers To
    Not transferable
    Description
    This course provides foundational knowledge of qual- ity control and regulatory compliance in the field of bio- technology as related to bioscience industries. Topics will include the product lifecycle, history of quality and reg- ulations; Food and Drug Administration (FDA) regulations for the biotechnology, pharmaceutical, medical device, and food industries; good manufacturing practices (GMP); quality systems; quality assurance and quality control; ISO (International Organization for Standardization) 9000 standards family; continuous improvement tools and strategies; types of regulated documents and good doc- umentation practices; resume/CV building and interview skills.