BTEC 222 Biotech Calibration and Validation (1)
Lec-9, Lab-27, (total hours)
Credit, Degree Applicable
PREREQ.: BTEC 221
An introduction to the theory and application of calibration and validation as applied to the Biotechnology Industry.
Offered on occasion
After successful completion of this course, students will be able to:
- Outcome 1: Relate biotechnology processes to each other.
- Outcome 2: Describe fundamentals of biological process validation.
- Outcome 3: Understand Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualification (PQ) protocols.
- Outcome 4: Describe the relationship of validation to Good Manufacturing Practices (GMPs)
- Outcome 5: Prepare validation protocols through case studies and exercises.
- Outcome 6: Describe the US Food and Drug Administration's (FDA) inspection expectations for qualification and validation of facilities, equipment and processes.
- Outcome 7: Describe the different types of validation documentation, their purpose, and how the documents are used by the FDA for GMP compliance.