FDA Regulatory Science Lecture: Principles of Risk Management
Thursday, October 10, 2013
Room 2116 Chemical and Nuclear Engineering Bldg.
Professor Keith E. Herold
Principles of Risk Management
Alford R. Taylor
Medical device manufacturers follow a structured process to manage the risk arising from the use of their products throughout the product life cycle. While FDA's interest in risk management focuses on the safety of the device, the risk management process is generic and may be used to address other kinds of issues, such as business risk, environmental risk, and patient privacy concerns. This lecture provides an introduction to the principles of risk management. Following this lecture, students should:
- understand the value of risk management,
- be able to outline the risk management process commonly used by medical device manufacturers,
- have a working familiarity (or at least a passing acquaintance) with established risk management terminology,
- be able to identify hazardous situations and make reasoned judgments concerning the adequacy of risks, and
- know where to go to obtain additional information about risk management.
About the Speaker
Dr. Alford R. Taylor joined the U. S. Food and Drug Administration in 1990. He oversees a group of electrical, software, and systems engineers who conduct research and provide technical consultations in regulatory matters involving medical device design and production. He divides his attention between engineering analysis and/or laboratory investigation of specific medical device design issues and the broader topics of quality and risk management. A large part of his group's research is focused on tools and methods for product development; i.e., helping product developers to get the design right the first time. He also oversees the development of custom instrumentation for FDA laboratory scientists.
Prior to joining FDA, Mr. Taylor gained extensive experience in the design of mission-critical electronic systems, including avionics and space-borne systems, nuclear power plant control systems, and air traffic control telecommunications systems. He earned the BS degree in Electrical Engineering from Carnegie-Mellon University in 1974.