Principles of Quality and Compliance

This course provides a foundational understanding of quality assurance and regulatory compliance in the biotechnology industry, with a focus on meeting global regulatory requirements and maintaining product quality and safety standards. Students will learn how key regulatory authorities, including the U.S. Food and Drug Administration, oversee compliance activities and enforce regulations that govern biotechnology and pharmaceutical operations. The curriculum covers core regulatory frameworks, Good Manufacturing Practice (GMP) requirements, quality systems, compliance strategy, risk assessment, and regulatory documentation processes used to support product quality and operational readiness. Learners will gain practical skills in quality management systems, compliance monitoring, documentation practices, risk evaluation, and implementation of quality standards within regulated biotechnology environments. This course prepares students for careers in quality assurance, regulatory compliance, quality control, and biotechnology operations within the pharmaceutical and biotechnology industries.