2019-2020 Course Catalog and Student Handbook 
    
    Feb 26, 2021  
2019-2020 Course Catalog and Student Handbook [ARCHIVED CATALOG]

BSCI 1212 - Instrumentation, Validation and Quality Assurance


Prerequisite: CHEM 1211  and CHEM 1211L  
This course provides an overview of documentation and validation concepts used within a biomanufacturing facility. Emphasis will be placed on source documentation, writing and executing Standard Operating Procedures (SOPs), process and equipment validation, as well as validation of bulk starting materials. A hands-on laboratory-based course that will familiarize students with some basic procedures and techniques common to laboratories involved with work that is covered by Quality Systems Regulation (QSR) and current Good Manufacturing Practices (cGMP). The principles of Good Laboratory Practices (GLP) and effective documentation procedures will be stressed. Contact hours: Class - 1, Lab - 5. Credit hours: 3 (Sp)