From July 23 to August 1, registrations for this course must be completed via form submission while we upgrade our registration system. Please direct any questions to email@example.com. Thank you for your patience while we work to improve your online experience.
This highly interactive 28-hour advanced course assumes that participants are experienced in working with an established ethylene oxide sterilization process, but are now challenged with ensuring the continued effectiveness and assessing change for the product or process. The program combines classroom lecture with real-life scenarios to illustrate concepts and situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios.
Topics to be covered include:
- validation and requalification;
- validation reports, protocols, and documentation;
- product adoption;
- process changes and process equivalency;
- product release methods;
- and optimization of sterilization process.
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.
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Gerry A. O’Dell, Clark W. Houghtling
Owner/President, Gerry O’Dell Consulting
Gerry O'Dellis 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 and Master of Science 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 the Association for the Advancement of Medical Instrumentation (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 EO 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.
Vice President, Business Development & Technical Affairs, Cosmed Group, Inc.
Clark Houghtling is the Vice President of Business Development & Technical Affairs for Cosmed Group, Inc. Originally named ETO Sterilization, Inc. (aka ETO), Cosmed was founded in 1981 to sterilize medical devices and spices. The company grew to be among the largest contract sterilization companies in the United States, until it divested its five medical device sterilization locations in 2005 to focus on food safety. The company continues to market technologies to pasteurize raw agricultural commodities in facilities dedicated to those purposes. The company recently reentered the medical device sterilization market and is manufacturing and selling ethylene oxide sterilizers, scrubbers and related accessories. Clark’s varied background includes extensive knowledge in sterilization technologies, finished goods testing, business development, plant and quality management, medical device manufacturing, sales, marketing, and regulatory affairs. Prior to this position, Clark worked in various upper management positions for companies including Comet ebeam Technologies, Synergy Health, Stryker Orthopaedics, Microtest Laboratories, and Cosmed/Steris. He holds a Bachelor of Science degree in Biology from the State University of New York at Geneseo, and attended graduate school in Biology at Niagara University. Clark has taught many courses and is a frequent lecturer to many varied groups including the Food and Drug Administration (FDA), the Association for the Advancement of Medical Instrumentation (AAMI) (where he serves as an instructor for the Industrial Sterilization for Medical Devices and the Industrial Ethylene Oxide Sterilization for Medical Device courses), the International Society For Pharmaceutical Engineers (ISPE), the Center For Professional Advancement (CPA), and for various companies. He is a member of the Sterilization Standards Committee at AAMI, the American Society for Microbiology (ASM), and a senior member of the American Society for Quality (ASQ). In addition, Mr. Houghtling served as Vice President of the Ethylene Oxide Sterilization Association (EOSA) and was an ASQ Certified Quality Auditor (CQA).