Learn how to achieve more successful testing outcomes by attending our Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing seminar in Salt Lake City, Utah. 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 industry-leading advisors from Nelson Labs and Sterigenics.
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: Bryce Telford
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: David Gilbert and Tony Vadnais
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: Helin Raagel, PhD
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: Robert Mueller
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: Logan Luke
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: Chris Hardman and Bryce Telford
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: Griffin Cammack
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: Erin Bakes
Check back for the agenda.
Registration cost is $900.
Deadline for all registrations is January 12, 2024.
Please note that the seminar registration fee does not include hotel accommodations.
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.