GXP (GOOD PRACTICE): WORKING IN A REGULATED ENVIRONMENT

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.

PHMSCI 751

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse pharmaceutical industry. 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.

PHMSCI 754

Explores business aspects of pharmaceutical product development and post-approval product maturation. Covers startup financing, risk management, intellectual property considerations, supply chain management, and strategic decision-making, as applied to both large and small pharmaceutical companies.

BIOMDSCI 721

Quality Assurance and Regulatory Affairs departments influence and facilitate successful product development within the biotechnology industry. Use a case study approach to explore and apply how quality assurance and regulatory compliance systems are used to bring medical devices to market. Practice how cross functional teams work together to meet regulatory standards of safety.

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.