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The Association for the Advancement of Medical Instrumentation (AAMI) will offer a two-part webinar to explain the process for introducing a novel sterilization process to a healthcare product and identify the regulatory hurdles that must be met. The event will be held July 26-27, 2016, from 11 a.m. to 1 p.m. EDT.
Turned into a two-part webinar (two hours on two consecutive days), this four-hour workshop will explain the process for introducing a novel sterilization process to a healthcare product and identify the regulatory hurdles that must be met. Attendees will learn how to define, validate and ultimately routinely control a novel sterilization process.
Upon conclusion of this program, attendees will finish with an outline of the regulatory requirements of ISO 14937 and other applicable regulations and have a clear understanding of the considerations and implementation strategies for new sterilization processes.
This program is designed for sterilization subject matter experts, R&D, and regulatory and manufacturing personnel of healthcare product manufacturers.
The speaker is Gerry O’Dell, 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 and master’s of science degree in microbiology from the University of South Florida and has more than 30 years of experience in the medical device industry.
Registration is $500 AAMI members and $580 for non-members. To register, CLICK HERE.