BIOS 2620 - Quality Assurance

4.5 Credits

This is the third course in the introductory biotechnology sequence. Students learn basic principles and practices of quality assurance (QA) and quality control (QC) in the biomanufacturing industry. Students explore how quality systems ensure product safety, consistency, and compliance with regulatory standards including the role that validation and verification processes play. Hands-on activities include mock inspections, testing of processes, product, and equipment, and evaluation of data to support quality decision-making in a biomanufacturing environment.

Prerequisites: (1) BIOS 2610

Recommended: BIOS 1450

Lecture Hours: 3.5
Lab Hours: 3.0
Internship Hours: 0.0
Clinical or Practicum Hours: 0.0

Course Objectives

Describe the importance of a Quality Management System in ensuring safety, efficacy, and regulatory compliance in biomanufacturing.
Explain the role of major regulatory agencies (such as FDA, USDA, and EPA) in overseeing biotechnology products and laboratory operations.
Differentiate between the functions and processes of the Quality Assurance and Quality Control departments in a biomanufacturing company.
Apply Good Documentation Practices (GDP) to ensure quality, compliance, and traceability.
Apply quality and continuous improvement systems such as CAPA (corrective and preventative action) and the PDCA cycle (Plan-Do-Check-Act).
Explain the consequences of noncompliance for a biomanufacturing company.
Perform quality control procedures related to processes, equipment, methods, and products based on standard testing processes.
Perform validation (qualification and calibration) of equipment.
Assess nonconformance and deviation events by using industry-specific problem-solving techniques such as root cause analysis, the 5 Whys, the Ishikawa (Fishbone) Diagram, and the Pareto chart.

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