Learn how to achieve more successful testing outcomes by attending Nelson Laboratories’ The Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing seminar in Frankfurt, Germany. 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 Labs’ and Sterigenics’ industry-leading advisors.
The Nelson Laboratories’ The Validation of Sterile Medical Devices seminar is RAPS and ASQ approved, eligible for 12 RAC and 1.2 ASQ credit hours. Course may also qualify for AAMI credit hours.*
COURSE HIGHLIGHTS INCLUDE:
European Union MDRs impact on device manufacturers
Reprocessing of surgical invasive devices, critical timeliness and technical documentation requirements under MDR
Speaker: Michael Maier
Senior Partner, Medidee Services SA
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: Wendy Wangsgard, PhD
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: Stefan Reisbacher
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
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: Annelies Vertommen, PhD and Sophie Michel, PhD
Nelson Labs Europe
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
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: Wendy Wangsgard, PhD
Speaker: Michele van Thournout
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: Emily Mitzel & Melissa Galle
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: Thor Rollins
Event Registration Info:
- Registration completed before February 20, 2020 is $949.00 USD
- Registration completed after February 20, 2020 is $1,100.00 USD
- Registration deadline is March 13, 2020
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 BOOKING DIRECTLY with the hotel. The cut-off date for your reservations will be March 9, 2020 (or until full). Nelson Laboratories has arranged special accommodations with with the Hilton Garden Inn Frankfurt City Center to provide room rates of €209 per night. This rate includes breakfast and wifi for each room.
Group Event Registration:
*As with all RAPS, ASQ, and AAMI credit hours, it is the responsibility of the individual to keep record of course participation and materials.