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Quality and Regulatory Compliance in Bioscience (IVC Biot 176)

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  • Page ID
    158735

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    This text provides a comprehensive overview of quality control, assurance, and regulatory environments within the biotechnology and biomanufacturing industries. Students study the role of the FDA, major regulatory frameworks (including the FD&C Act), and critical industry compliance systems like Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). It also spans ISO standards, Quality Management Systems (QMS), and how to author or validate standard operating procedures (SOPs).

    This page titled Quality and Regulatory Compliance in Bioscience (IVC Biot 176) was last modified on Mon, 09 Nov 2026 06:29:30 GMT and is shared under a CC BY-SA 4.0 license and was authored, remixed, and/or curated by Emalee MacKenzie.