Topics Include:

General Microbiology: A general background of the terms, definitions, and concepts of microbiology.

General Sterilization: A general background of the terms, definitions, and concepts for sterilization and related testing.

Ethylene Oxide Sterilization: Understand the basic testing requirements and methods

• Discover the history and background
• Case studies and data evaluation
• IQ, OQ, PQ
• AAMI Update

Radiation Sterilization: Understand the basic testing requirements and methods

• Discover the history and background
• Case studies and data evaluation
• How to interpret your bioburden data
• Validation & audit failures

Biocompatibility: Understand the basic testing requirements and methods. How to classify your product according to the ISO 10993 Standard

Packaging Validation: Overview of packaging criteria and test methods

Alternate Sterilization: Basic testing requirements and methods for:

• STERRAD
• Steam
• VHP
• Dry Heat

Materials Compatability: Materials qualification for all sterilization processes

• Basic polymer chemistry in relation to sterilization
• Accelerated aging programs
• Package selection for sterilized products
• Materials selection for product

Speakers

Jerry R. Nelson, Ph.D., Laboratory Director
Member of AAMI Sterilization Committee

Martell Winters, B.S. Microbiologist
Member of AAMI Sterilization Committee

Dan Floyd, B.S. Microbiologist
Member of AAMI Sterilization Working Group

Amy Karren, B.S. Microbiologist
Member of AAMI Sterilization Working Group

Thor Rollins, B.S. Microbiologist
Member of AAMI Biological Evaluations Working Group

Karl Hemmerich, M.S. Plant Manager
STERIS Isomedix- Sandy, Utah

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

DoubleTree Hotel San Jose- 2050 Gateway Place, San Jose, CA. 95110

For the convenience of our seminar guests, Nelson Laboratories has set aside guest rooms at the DoubleTree Hotel. The special rate for this seminar has been set at $195.00 per night plus tax (Standard- Single/Double rate). This rate is guaranteed for reservations made by August 29, 2008 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 DoubleTree Hotel reservation office at 408-453-4000. Inform them you're with the Nelson Laboratories Workshop. Please use the code: NL1 when making reservations. Reservations also can be made on the internet by clicking here.

REGISTER NOW!