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Radiation Sterilization for Medical Devices

Learn to navigate FDA expectations and gain a comprehensive understanding of the ANSI/AAMI/ISO 11137 series of radiation sterilization standards.

About the course:

This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. Some of the topics covered are:

  • FDA expectations regarding successful submissions, inspections, recalls, problem solving, and risk avoidance
  • Scientific theory and principles of radiation sterilization
  • The 11137 series of radiation sterilization standards

Participants will learn integration of industry standards with the U.S. Quality System Regulation, auditing processes for contract laboratories and sterilizers, and 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 course includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references.

 

Who should take this course?

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.

Registration:

AAMI Members:Nonmembers:Government Employees:
$2,700$3,000$1,080


Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.

For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.