Join Nelson Labs for our first Asian seminar on Sterile Medical Device Validation!
The purpose of this seminar is to provide medical device professionals with a comprehensive understanding of preclinical testing requirements, with a focus on ISO standards and the FDA’s unique approach to testing and submissions. As regulatory expectations continue to evolve, it is crucial for companies to navigate the complexities of international compliance effectively.
This seminar will offer in-depth insights into best practices for preclinical testing, ensuring safety and efficacy while streamlining the regulatory submission process. Attendees will gain valuable knowledge on aligning their testing strategies with both ISO standards and FDA guidelines, ultimately enhancing their ability to bring innovative medical devices to market efficiently and successfully.
Seminar participants will receive expert instruction from industry leaders at Nelson Labs, ensuring a comprehensive and insightful learning experience.
Translation will be provided from English to Japanese
This seminar is RAPS and ASQ approved and is eligible for 12 RAC and 1.2 ASQ credit hours. Courses may also qualify for AAMI credit hours.*
COURSE HIGHLIGHTS INCLUDE THE FOLLOWING:
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, RM/SM (NRCM), CISS-RAD, Scientific Competency Expert, Nelson Labs
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: Martell Winters, RM/SM (NRCM), CISS-RAD, Scientific Competency Expert, Nelson Labs
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 a biocompatibility overview, 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: Thor Rollins, RM (NRCM), VP Global Segment- Medical Device, Nelson Labs
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: Thor Rollins, RM (NRCM), VP Global Segment- Medical Device, Nelson Labs
Packaging Fundamentals – Design and Validation Considerations
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: Martell Winters, RM/SM (NRCM), CISS-RAD, Scientific Competency Expert, Nelson Labs
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, RM/SM (NRCM), CISS-RAD, Scientific Competency Expert, Nelson Labs
Cleaning, Disinfection, and Sterilization Validations of Reusable Medical Devices
This training will teach attendees the information and processes involved in the validation of health care 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: Alpa Patel, M.S., RM (NRCM), Director of Lab Operations (Healthcare Reprocessing)
Don’t miss this opportunity to enhance your expertise and connect with professionals shaping the future of medical device validation. Register now!
Registration Details:
Registration is $500.
Deadline for all registrations is Sep 26, 2025.
Groups of three or more may contact Mike Pizzi at [email protected] or +1 (801) 290-7524 for information about discounted pricing.
Hotel Accommodations:
Guests planning to stay on location may coordinate their hotel reservation with Hilton Tokyo Bay for a discounted rate.
Deadline for hotel booking with the discount rate is Sep 5, 2025.
Please note that the seminar registration fee does not include hotel accommodations.
Other Details:
Lunch and refreshments will be served daily and are included in the seminar package.
*As with all RAPS, ASQ, and AAMI credit hours, it is the responsibility of the individual to keep record of course participation and materials.
Alpa Patel, M.S., RM (NRCM)
Director of Lab Operations (Healthcare Reprocessing)
Alpa Patel is a certified microbiologist and has been part of the medical device industry for 20 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a Director of Lab Operations (Healthcare Reprocessing) at Nelson Labs involves overseeing test method validations...
Martell Winters
RM/SM (NRCM), CISS-RAD
Scientific Competency Expert
Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.
Thor Rollins
RM (NRCM)
Biocompatibility Expert
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...
