TOPICS IN QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

BIOMDSCI 722

Leaders in the Quality Assurance and Regulatory Affairs departments influence and facilitate bringing products to market within the biotechnology industry. Focus on building communication among cross functional teams; exercising writing to specific audiences; and meeting internal and external customer needs and expectations. Explore and apply how quality and regulatory affairs skills are managed within diverse product and project teams.

ABT 745

Examines regulatory environments in risk-based assessment of biotechnological developments in industry, agriculture, and probiotics ensuring consumer and environmental protection. Addresses how validation is essential to the incorporation of emerging technologies into viable, accessible, and successful products. Highlights the stakeholders' role in regulatory oversight and policy through relevant industry case studies.

BIOMDSCI 720

Success in the biotechnology industry is based on learning the language and understanding the development process utilized in bringing products to market. Focus on techniques used in the biotechnology industry to comply with the quality and regulatory requirements set forth by professional and governmental agencies in the effort to develop, manufacture, and commercialize products safely for the public.

BIOMDSCI 801

Explore political, legal, and ethical issues and paradigms that drive product development within the biotechnology industry with special emphasis given to how new drugs, devices, and biologics are regulated by local, national, and global agencies. Describe the regulations and ethics of human subjects' research. Develop skills to support how regulation and politics interact with business and finance to influence the formation and growth of biotechnology companies. Discuss how ethics and regulatory policy influence how biotechnology products come to market.

ABT 740

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry, both domestically and internationally. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.