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A 3½ day program from the Association for the Advancement of Medical Instrumentation (AAMI), "Radiation Sterilization for Medical Devices," covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices.
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.
The program will be held Oct. 7-10, 2014 at The Westin Alexandria, 400 Courthouse Square in Alexandria, Va.
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.
In consultation with industry, government leaders, and educational experts, this course was developed to meet the medical device industry’s need for a better understanding of radiation sterilization principles, standards, and methods. The course will be taught by a mix of independent experts and industry representatives experienced in radiation sterilization. Instructors will provide a balanced presentation of radiation sterilization principles and practices as described in topics above.
Registration costs are $2,035 for AAMI corporate and institutional members; $2,135 for AAMI individual members; $2,535 for nonmembers; and $635 for government employees. For more details, visit: http://www.aami.org/meetings/courses/radiation.html