RABE 120

Regulatory Science and Quality Control

Regulatory compliance is a critical factor in bringing biotech products to market. This course equips students with the knowledge to navigate complex regulatory landscapes and ensure product safety and efficacy. This course provides an overview of regulatory frameworks governing biotechnology products, focusing on FDA, EMA, and other global regulatory bodies. Students will explore key concepts in quality control, validation processes, and compliance strategies. The course covers topics such as risk assessment, documentation, and regulatory submission processes. Practical exercises will help students navigate regulatory pathways for product approvals. Industry case studies will provide insights into the challenges of maintaining compliance in a rapidly evolving field. Mastery of regulatory science helps biotech companies avoid costly delays and legal challenges.