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The Association for the Advancement of Medical Instrumentation (AAMI) will offer the course, Radiation Sterilization for Medical Devices, Oct. 31 to Nov. 3, 2016, in Arlington, Va. This course providing intensive coverage of principles, processes, best practices and industry standards in radiation sterilization for medical devices. Some of the topics covered are: FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance; scientific theory and principles of radiation sterilization; and the new 11137 series radiation sterilization standards.
The course examines:
•FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance
•Scientific theory and principles of radiation sterilization
•The new global ANSI/AAMI/ISO 11137 series on radiation sterilization standards
•Integration of industry standards with the Quality System regulation
•Sterility Assurance Levels (SALs)
•Auditing processes for contract laboratories and sterilizers
•Radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations
This course is designed to be highly interactive between faculty and participants and will include relevant real-life examples and “hands-on” exercises from a broad spectrum of medical device products.
This course is for professionals currently working in or with sterilization processes, particularly related to radiation sterilization. This includes design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended they have a working knowledge of general sterilization principles.
•Mark A. Smith, PhD, CHP, Ionaktis, LLC
•Gerry O'Dell, President, Gerry O'Dell Consulting (via teleconference)
•Pat Weixel, Consumer Safety Officer, FDA/CDRH/OC/DEA
Registration is $2,235 for AAMI members and $2,535 for non-members. The rate for government employees is $735. For more details and registration, CLICK HERE.