Nelson Laboratories (Salt Lake City), a provider of full life cycle microbiology testing services, is offering a seminar and workshop on ethylene oxide (EtO) and radiation sterilization for medical devices August 25–26. Featuring presentations from several of the company's scientists, the event also will include an overview of U.S. and global regulatory strategies—and how to align them with a company's business strategies—presented by Clay Anselmo, president and CEO of Reglera (Lakewood, CO), a regulatory consulting company. Kicking off the event, Dan Floyd, manager of Nelson Labs' EtO department, will present EtO case studies and data to help attendees gain an understanding of the basic requirements and methods of the technology. In addition to offering some background on EtO, Floyd will explain the purpose and use of biological indicators and process challenge devices, as well as how to validate a sterilization process. Martell Winters, a senior scientist at Nelson Labs, will cover radiation sterilization. Winters will outline the different radiation methods currently used, and will explain how to interpret bioburden data and address audit failures. The two-day seminar will also include presentations offering a general background of microbiology and sterilization concepts, including packaging sterilization, from Jerry Nelson, Nelson Labs' laboratory director. To help attendees gain a better understanding of different types of biocompatibility tests, Thor Rollins, a microbiologist at Nelson Labs, will explain the tests and how to interpret their results. Rollins also will demonstrate how to categorize products for biocompatibility testing according to the ISO 10993 table. In addition to medical device and packaging engineers, members of industry involved in quality assurance and control, validation, research and development, and product management may benefit from attending the workshop, according to the company.
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