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Science of Sterilization Validation Seminar, San Diego 2017

Event Date(s): Location: Contact Information:
November 14, 2017 - November 16, 2017
1646 Front Street
San Diego, California, 92101
Mike Pizzi

Learn how to achieve more successful testing outcomes by attending Nelson Laboratories' Science of Sterilization Validation seminar in San Diego.The aim of this three-day seminar is to provide MedTech professionals the opportunity to establish or refresh their fundamental testing knowledge and, thereby, achieve more efficient, accurate, and effective testing outcomes.

Seminar participants will enjoy classes taught by Nelson Laboratories' industry-leading scientific community including Martell Winters, Thor Rollins, Paul Littley, Wendy Mach, and Matt Jorgensen.

The Nelson Laboratories' Science of Sterilization Validation seminar is RAPS and ASQ approved, eligible for 12 RAC and 1.2 ASQ credit hours. Course may also qualify for AAMI credit hours.*

*Agenda will be available soon for download (times and topics subject to change).


Introduction to Microbiology & Sterilization:
This course offers attendees an opportunity to brush up on the basics of sterilization, microbiology, and important medical device industry terms.

Speaker:Martell Winters,SM (NRCM)
Senior Scientist,Nelson Laboratories
Member of AAMI Sterilization Committee

Ethylene Oxide Sterilization Validation:
Learn how to develop, optimize, and validate a successful ethylene oxide sterilization process that delivers the necessary sterility assurance level and ensures repeatability.

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 involved in completing 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: Paul Littley, ASQ, ISPE                                                     Speaker: Tim Bollnow
Consulting Manager, Nelson Laboratories                                  SteriPro Consulting
Member of AAMI Sterilization Working Group                           
Biocompatibility / ISO 10993:
With 24 possible categories, the biocompatibility testing experience can be intimidating. This course will help you understand the testing requirements of ISO 10993 and how to choose the correct test methods for your product.

In addition to abiocompatibilityoverview, this course will highlight key terms and definitions, a general overview of each of the test options, and applicable case studies. Lastly, this course will teach you how to categorize your product according to the ISO 10993 table.

Speaker: Audrey Turley,RM (NRCM), CBA(ASQ)
Biocompatibility Technical Consultant,Nelson Laboratories
Chemical Characterization:
This course will help you understand the analytical chemistry techniques that can be used to characterize device materials and evaluate extractable/leachable compounds.

This testing is being used in the industry to evaluate changes made to device materials and processing as well as supplement biocompatibility testing. These test methods are becoming a popular alternative for animal testing.

Speaker: Matt Jorgensen, PhD
Consulting Manager,Nelson Laboratories
Chemistry & Materials Scientist
Packaging Overview / ISO 11607:
Focused on the requirements outlined in ISO 11607, this course will help you understand packaging validations and how to successfully navigate the package testing arena.

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.

Speaker: Wendy Mach,RM (NRCM), CQA (ASQ)
Manager of Packaging Department,Nelson Laboratories
Member of AAMI & ASTM Working Groups
Radiation Sterilization Validation:
This class teaches students how to perform radiation validations, review bioburden data, deal with sterility test failures, and understand the various radiation options (gamma, electron beam, and X-ray).

Training begins with the fundamentals of Radiation including the background of gamma and radiation, and key terms and definitions. This training then highlights 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,SM (NRCM)                                            Speaker: Niki Fidopiastis
Senior Scientist, Nelson Laboratories                                          Director, SteriPro Consulting
Member of AAMI Sterilization Committee                                  Member of AAMI Sterilization Committee

Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices:
This training will teach attendees the information and processes involved in the validation of healthcare device reprocessing instructions. Highlights include discussion of the guidance documents, standards, industry trends, and the acceptance criteria including contamination, cleaning, extraction, and residual testing for cleaning validations. Course will also cover how to plan for and perform each of these validations as well as simulated use and end of life testing. The disinfection training will include disinfection classifications and acceptance criteria as well as neutralization, inoculation, disinfection methods and solutions, extraction, and testing methods. The sterilization validations training will include inoculation, parameters for sterilization, dry time testing, and temperature profiling.

Speaker: Emily Mitzel, B.S.
Consulting Manager, Nelson Laboratories
Member of AAMI Sterilization Committee
Cleaning Validations for Newly Manufactured Devices and Single Use Implants:
The importance of manufacturing clean devices will be discussed during this course, and how cleanliness should be evaluated in addition to the sterility and biocompatibility of a device.

Topics of discussion will include test methods to evaluate manufacturing and cleaning residues, along with information regarding sampling, routine monitoring, and determining acceptance criteria.

Speaker: Matt Jorgensen, PhD
Consulting Manager, Nelson Laboratories
Chemistry & Materials Scientist

Preparing Your FDA Submission:
What does FDA want to review when it comes to packaging, cleaning, reprocessing, sterilization, and biocompatibility? This session will incorporate what you've learned this week and provide insight into what FDA expects in your regulatory submissions. Providing too much information can lead to a lengthy review process, whereas providing too little can lead to frustrating hold letters from FDA.  We will discuss how to submit the right information as well as the right amount of information.  Attendees will go through case studies and learn from recent deficiencies from FDA hold letters. 

Speaker: Allison Komiyama, PhD., R.A.C.
AcKnowlege Regulatory Strategies, LLC

- Early bird registration: $799.00 per person
- Registration completed after October 13, 2017 is $925.00
- Registration deadline is October, 30, 2017.

Lunch and refreshments will be served daily and are included in the seminar package. Please note, however, that the registration fee does not include hotel accommodations.
Guests planning to stay on location may coordinate their hotel reservation by callingthe hotel directly at 619-239-6800 (8:00 AM- 5:00 PM PST) or 1-800-222-TREE (24 hours a day) and identify themselves as being with the group, Nelson Laboratories Science of Sterilization Validation seminar. The cut-off date for your reservations will be October 23rd (or until full). A negotiated rate of $189.00 per night has been worked out with the hotel.
Groups of three or more may contact Mike Pizzi at mpizzi@nelsonlabs.comor 801-290-7524 for discounted pricing information.

*As with all RAPS, ASQ, and AAMI credit hours, it is the responsibility of the individual to keep record of course participation and materials.

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About Nelson Laboratories, LLC

Established in 1985, Nelson Laboratories is a leading provider of microbiological testing and consulting services for MedTech companies. We know that every test matters and requires solutions that improve patient outcomes and minimize customer risk. We call it "The Science of Success®." It means working with customers to solve complex problems, providing precise test results, and delivering value through superior testing solutions and service to ensure the safety and efficacy of every product. Nelson Laboratories is a standalone business within Sterigenics International LLC, the global leader in outsourced contract sterilization services, gamma technologies, and medical isotopes. Visit for more information.

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