Nelson Laboratories Seminars
Nelson Laboratories conducts educational seminars for the medical device industry to those interested in learning more about a wide range of microbiological, sterilization, and biocompatibility test methods. Topics are presented by representatives in the industry who are active contributors of the AAMI/ISO committees.
The Science of Sterilization Validation
Salt Lake City, UT- Registration CLOSED
Location: Salt Lake City, UT.
Embassy Suites Hotel
Date: March 1-3, 2010
9:00AM to 5:00PM
Cost: $915.00 before February 5, 2010
$1,150.00 after February 5, 2010
Registration Deadline: February 15, 2010 or until full
* Registration fee does not include hotel accommodations
Topics & Speakers Include:
General Microbiology: This presentation is designed to provide a general background of the terms, definitions, and concepts of microbiology.
Speaker: Jerry R. Nelson, Ph.D., Chief Science Officer
Nelson Laboratories, Inc.
Member of AAMI Sterilization Committee
General Sterilization: A general background of the terms, definitions, and concepts for sterilization. A general overview of the different types of sterilization methods will be discussed.
Speaker: Jerry R. Nelson, Ph.D., Chief Science Officer
Nelson Laboratories, Inc.
Member of AAMI Sterilization Committee
Ethylene Oxide Sterilization: Understand the basic testing requirements and methods
- Discover the history and background
- Case studies and data evaluation
- The purpose and use of biological indicators
- How and when to use a process challenge device (PCD)
- IQ, OQ, PQ
- How to validate your sterilization process
- AAMI Update
Speaker: Dan Floyd, B.S. Manager of Ethylene Oxide Department
Nelson Laboratories, Inc.
Member of AAMI Sterilization Working Group
Radiation Sterilization: Understand the basic testing requirements and methods
- Discover the history and background
- Case studies and data evaluation
- Explanation of the different methods including Method 1 & 2 and VD Max
- How to interpret your bioburden data
- Validation & audit failures
Speaker: Martell Winters, B.S. Senior Scientist
Nelson Laboratories, Inc.
Member of AAMI Sterilization Committee
Biocompatibility: This presentation is designed to help you understand what the basic testing requirements are and how to categorize your products according to the ISO 10993 table. The presentation also covers each of the different biocompatibility tests to show why each one is used and how to interpret the results.
Speaker: Thor Rollins, B.S. Manager of In-vivo Biocompatibility
Nelson Laboratories, Inc.
Member of AAMI Biological Evaluations Working Group
Regulatory Approval Process and Strategy Development for Medical Devices
This presentation is designed to provide an overview of key elements of US and worldwide regulatory strategies and how to align them with other business strategies.
Speaker: Clay Anselmo, B.S. President and CEO,
Reglera, LLC
Member of Regulatory Affairs Professionals Society
Reusable device validations for sterilization, cleaning and disinfection:
- Understand the basic testing requirements and methods
- Steam sterilization validation: What are the acceptance criteria and how to perform a sterilization validation
- Cleaning validation: How to determine what contamination methods and residual testing is appropriate for specific device types and what acceptance criteria should be utilized.
- Disinfection validation: How to determine what level of disinfection should be claimed, the acceptance criteria of each level, and the testing associated with meeting that level of disinfection.
- AAMI update on the revisions of TIR30: 2003 and TIR12: 2004
Speaker: Emily Mitzel, B.S., M.S. Manager of Hospital Reprocessing Dept.
Nelson Laboratories, Inc.
Member of AAMI Sterilization Committee
Introduction to Medical Device Packaging:
- This presentation is designed to discuss the general advantages and disadvantages of packaging attributes. This topic will review the packaging attributes for Gamma, E-Beam, Autoclave, and Ethylene Oxide sterilization. An overview and explanation of bags and pouches, heat seal versus cold seal coatings, blown film versus cast film extrusion, and adhesive lamination versus extrusion lamination will also be discussed.
Speaker: Rick Merical
Alcan Packaging
Package Testing:
- This presentation will focus on the values and methodology of package testing with a focus on the requirements outlined in ISO 11607.
Speaker: Wendy Mach, B.S., Manager of the Packaging Dept.
Nelson Laboratories, Inc.
Member of ASTM & AAMI Committees
Tour of the Nelson Laboratories Campus:
A highlight of the seminar will be a tour of our newly remodeled facility including our new 48,000 sq. ft. addition. Come and see what takes place in a microbiology lab.
Who Should Attend:
- QA/QC
- Regulatory Affairs
- Sterility Assurance Specialist
- Validation Coordinators
- Product and/or Packaging Engineers
- Product management
- Medical Device R&D
- A must for anyone in the Medical Device Industry
"Wonderful workshop! Even as a newcomer to the field I had an understanding of everything that was discussed, but walked away feeling a much more in depth knowledge."
"I wanted to send along my THANKS for putting on such a great workshop. I definitely have a better understanding of what needs to happen here at my company to ensure the safety of our patients."
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.
Hotel Information
Embassy Suites Hotel- 110 W. 600 S. Salt Lake City, UT 84101
For the convenience of our seminar guests, Nelson Laboratories has set aside guest rooms at the Embassy Suite Hotel. The special rate for this seminar has been set at $139.00 per night plus tax (Standard- Single/Double rate). This rate is guaranteed for reservations made by February 1, 2010 or until the discounted rooms are sold-out, whichever comes first. Guest rooms are available for reservation (at the special rate) three days prior and three days after the event.
To book reservations please contact the Embassy Suites Hotel reservation office directly at 801-359-7800. Inform them you are with the Nelson Laboratories Workshop.
For groups of three or more, contact Jared Forsyth for special discounts.