Science and technology are moving at an increasingly rapid pace, with pressure on industry to get new products to market swiftly while assuring consumers and regulatory agencies that these products are effective and safe. The food, pharmaceutical, and biotechnology industries are challenged to develop processes and procedures to ensure that products meet quality and regulatory standards. Thus, today's laboratory scientist must possess the knowledge, expertise, and skills to create and implement efficient and effective quality systems as well as understand the regulatory and compliance environment. Other essential skills include project management, risk assessment, and risk management. Efficient risk management requires developing quality standards, using the best scientific data, and employing practices that result in clear and consistent decisions and clear communications with the public and regulatory agencies. In the MQARS program Northwestern University has created an industry-standard graduate program in quality and regulatory issues to serve an audience of practicing scientists in the pharmaceutical, food, and biotechnology industries. The program's 10-course curriculum is designed to bridge the gap between traditional academic programming in the life sciences and the quality assurance and regulatory demands of industry. Scientists holding undergraduate and graduate degrees in fields such as biology, chemistry, bioengineering, biotechnology, and chemical engineering routinely find themselves asked to play a leadership role in quality assurance, yet they are unlikely to have any formal education in this area or possess current knowledge in this increasingly complex field. Pharmaceutical, food, medical device, and other similarly regulated industries face many overlapping quality challenges that are better addressed by a professional master's degree than by internal training programs.