BSCI 1212 - Validation, Documentation and Quality Assurance

Prerequisite: CHEM 1211 and CHEM 1211/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. Note: This course requires a supply reimbursement charge. Contact hours: Class - 1, Lab - 5. Credit hours: 3 (Sp)

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