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.
Dates: October 27-30,2020
Times: 8:00AM-5:00PM ET (Days 1-3)
8:00AM-12:00PM ET (Day 4)
Meet the Faculty:
Owner/President, Gerry O’Dell Consulting
Gerry O'Dell is owner and president of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Gerry O'Dell Consulting works to assist companies of all sizes to comply with requirements during design, development, and manufacturing to assure that single-use products are sterile and that reusable medical devices can be processed effectively. Prior to starting Gerry O'Dell Consulting in 1998, she worked for Johnson & Johnson as a manager of laboratory & sterilization services; the department charged with oversight of the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. She holds both a bachelor's degree and a master's degree in microbiology from the University of South Florida and has over thirty years of experience in the medical device industry. Gerry O’Dell is a member of AAMI and actively participates in the sterilization standards committee activities. She is currently co-chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and a member of the U.S. Sub-TAG for ISO/TC 198/WG 1. She is also a member of the most of the sterilization related working groups and several of the groups related the processing of reusable medical devices. Gerry is lead instructor for the AAMI industrial ethylene oxide sterilization course, is an instructor for the industrial radiation course and has presented several webinars through ComplianceOnline related to environmental monitoring excursion, testing failures, PCD development and reusable device cleaning validations. Gerry is a registered microbiologist with the National Registry of Microbiologists in the area of consumer products & quality assurance. She is also a member of the American Society for Microbiology (ASM), American Society for Testing & Materials (ASTM), and PDA.
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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 firstname.lastname@example.org.