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Topics to Include:
General Microbiology
This topic is designed to provide a fundamental background of Microbiology. Definitions of key terms, microorganisms and how they relate to your products along with where they come from are discussed. Overall the purpose of this presentation is to provide a baseline building block which will assist in the learning of the remaining presentations.
Speaker: Jerry R. Nelson, Ph.D. Chief Science Officer
Nelson Laboratories, Inc.
Member of AAMI Sterilization Committee
General Sterilization
This topic is designed to provide a fundamental background of Sterilization. Definitions of key terms, the different types of sterilization methods available, and how to prevent contamination of your product in the cleanroom are discussed too. Overall the purpose of this presentation is to provide a baseline building block which will assist in the learning of the remaining presentations.
Speaker: Jerry R. Nelson, Ph.D. Chief Science Officer
Nelson Laboratories, Inc.
Member of AAMI Sterilization Committee
Ethylene Oxide Sterilization Validation
This topic is designed to provide information for the beginner and the intermediate level person seeking further details into the Ethylene Oxide sterilization process. The training starts with the fundamentals of the Ethylene Oxide process beginning with the history, purposes and uses of it. The training then leads into the steps needed in order to complete a validation including comparative resistance testing, the use of biological indicators in combination with process challenge devices (PCD) and cycle development. Lastly the topic covers several of the standards along with case studies and examples.
Speaker: Dan Floyd, B.S. Laboratory Manager
Nelson Laboratories, Inc.
Member of AAMI Sterilization Working Group
Radiation Sterilization Validation
This topic is designed to provide information for the beginner and the intermediate level person seeking further details into the Radiation sterilization process. The training starts with the fundamentals of Radiation including the background of gamma and radiation and the necessary key terms and definitions. The training then describes how and why bioburden testing is completed. The different types of methods for doing radiation sterilization including VD Max, Method 1 and Method 2 are discussed in detail. Lastly the topic covers several of the standards along with case studies and examples.
Speaker: Martell Winters, B.S. Senior Scientist
Nelson Laboratories, Inc.
Member of AAMI Sterilization Committee
Steam Sterilization & Cleaning Validation of a Reusable Medical Device:
This topic is designed to provide information for the beginner and the intermediate level person seeking further details into performing sterilization and cleaning validations of reusable medical devices. The training starts with the fundamentals of each sterilization process and goes into more depth about the types of BIs, determining inoculation sites, dry time validations, and residual testing. The topics also covers the fundamentals of the cleaning process and goes into more depth about how to contaminate and perform the dwell time of the devices, what methods are used to clean the devices, what residuals are appropriate to test for specific device types, and the acceptance criteria for each residual tested. Lastly the topic covers several of the standards along with case studies and examples.
Speaker: Emily F. Mitzel, M.S., B.S. Laboratory Manager
Nelson Laboratories, Inc.
Member of AAMI Working Groups
Biocompatibility
This topic is designed to provide an overview of the requirements for Biocompatibility. Definitions of key terms, general overview of each of the test options, and case studies are also discussed. Lastly how to categorize your product according to the ISO 10993 table is reviewed.
Speaker: Thor Rollins, B.S. Manager of In-Vivo Biocompatibility Department
Nelson Laboratories, Inc.
Member of AAMI Biological Evaluations Working Group
Packaging Overview
This topic is designed to provide a general background of the packaging standards and what options are available for completing a validation. Several of the different types of tests are discussed along with the purposes and data they provide. Lastly the topic covers case studies and examples.
Speaker: Wendy Mach, B.S., Manager of Packaging Department
Nelson Laboratories, Inc.
Member of AAMI & ASTM Working Groups
Cleaning Validations for Newly Manufactured Devices
This presentation outlines an approach to the validation of cleaning processes for newly manufactured devices. This presentation defines a cleaning validation, describes when to validate, the benefit of performing a cleaning validation, and provides information on sampling plans. This presentation will also cover three test that can be used to demonstrate device cleanliness; Total Organic Carbon (TOC), Gravimetric Analysis (ASTM F2459-05) and Detergent Residual Analysis by Ultraviolet Spectroscopy (UV/Vis). Lastly, justification of residue levels will be discussed along with case studies and examples.
Speaker: Alexa Tatarian
Nelson Laboratories, Inc.
Continental breakfast, lunch, and snacks will be served each day. Session breaks will also provide attendees an opportunity to discuss specific questions with speakers and industry guests who are representatives in their field/application.
Tours of Nelson Laboratories will be available during the seminar
Payment Information
Cost per person is $425.00. After 27 February 2012, the cost is $550.00. Registration ends 05 March 2012
* Registration fee does not include hotel accommodations.
For groups of three or more, please contact Jared Forsyth by email or at 801-290-7551 for discounted pricing information.
Hotel InformationHilton Garden Inn SLC Downtown 250 W 600 S Salt Lake City, UT 84101
For the convenience of our seminar guests, Nelson Laboratories has set aside guest rooms at the Hilton Garden Inn. The special rate for this seminar has been set at $149.00 per night plus tax (Standard- Single/Double rate). This rate is guaranteed for reservations made by 24 February 2012 or until the discounted rooms are sold-out, whichever comes first.
To book reservations please call the Hilton Garden Inn at 801-364-5200 and let them know you are with the Nelson Laboratories Sterilization Seminar. |