The Association for the Advancement of Medical Instrumentation (AAMI) is a unique alliance of over 6,000 members united by the common goal of increasing the understanding and beneficial use of medical instrumentation.

Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization processing in a medical device-manufacturing environment. Developed by medical device manufacturers, the U.S. Food and Drug Administration (FDA), and industry consultants, the course addresses sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.

Course Objectives are to teach participants how to apply the principles of sterilization, address sterilization requirements during product design, select and implement an appropriate sterilization process, identify the elements of successful sterilization validation, describe the critical parameters of a chosen sterilization process, participate in the design of process validation for moist heat, ethylene oxide (EO) and radiation sterilization processes, compare and contrast sterilization cycle developments, correlate appropriate standards with sterilization processes and identify requirements pertinent to validation, packaging and routine process control and describe critical factors in making product release decision and identifying resources for complying with FDA requirements.


This highly interactive program combines classroom lecture with situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. In addition, participants will work through a series of case studies illustrating problematic situations. Case studies will cover various aspects and phases of sterilization processes...from design, to cycle development, to validation, to process control, to product release.

This is a four-day course with materials provided. It is recommended for those who are relatively new to the sterilization process environment and need information to help them better understand the principles and science of industrial sterilization. This course is designed for professionals such as design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, or others directly involved in sterilization processes and responsible for meeting industry standards and FDA requirements.

The course will be held on February 25-28 at the Hyatt Regency Atlanta and October 13-16 at The Westin Arlington Gateway in Virginia. The faculty of this course will consist of industry leaders, independent experts and FDA personal. Fee includes materials and continental breakfast, lunch and refreshments. Fees are $1885 for AAMI corporate and institutional members, $1985 for individual members, $2385 for non members and $585 for government employees. For more information go to www.aami.org/meetings/courses/ster.html