This lecture course introduces students to quality control (QC) practices in biotechnology, emphasizing regulatory compliance, Good Documentation Practices (GDP), contamination testing, analytical methods, and documentation standards. Students will explore sterility assurance, analytical instrumentation, and interpretation of quality data through case studies, including corrective and preventative action (CAPA) and out-of-specification (OOS) scenarios. Graduate students will additionally design and defend QC protocols in the context of regulatory frameworks, potential errors, ethics, and translational applications. Dual-listing: MICR 673.