Date/TimeDate(s) - June 1, 2021
09:00 AM - 04:30 PM CEST
*** VIRTUAL EVENT ***
9:00 am – 4:30 pm Central European Summer Time
Attendees will receive all the perks of NAMSA’s highly sought-after in-person workshop while in the comfort of their own home or office! This interactive, educational training will provide hands-on training, open discussion with industry peers, Q&A with NAMSA’s testing experts and attendee networking.
Registrants will receive course training workbooks that will be sent directly to their identified shipping* address (home or office). Course certificates will be electronically sent upon completion of the training.
*Please ensure that your “shipping” address is where you would like your course materials to be mailed. If this address is the same as your billing address, please indicate “same as above” when registering. NOTE: Our security measures require that your credit card billing address match your profile address.
The chemical and physical characterization of materials and devices has long been considered an important step in evaluating biological safety. The most recent revisions of ISO 10993-1:2018 and ISO 10993-18:2020 continue to emphasize the importance of this evaluation and potential testing needs.
As global regulatory bodies adjust to applying the new ISO 10993-18: 2020, manufacturers must understand the potential nuances of this new regulation. For example, EU Notified Bodies may require additional evaluation as the Medical Device Regulation (MDR) looms closer, while the U.S. Food & Drug Administration (FDA) has placed an increased emphasis on characterization and requests very specific requirements as outlined in the 2016 guidance document (while continuing to expand the use of the analytical data). The successful implementation of this standard, and evaluation outlined in supporting documents, is critical for medical device manufacturers if they wish to stay on track with market clearance plans.
In this online session, NAMSA will discuss the chemical characterization of materials and the evaluation steps to choose proper tests, extracts and test durations to meet the latest industry requirements. This workshop will include instruction via our virtual training platform, as well as multiple hands-on exercises guided by an experienced NAMSA instructor.
Upon completion, attendees will be able to:
- Relate ISO 10993-18:2020 to ISO 10993-1:2018 and the biological evaluation of devices
- Discuss the changes in the new document in a practical use format
- Discuss how material and chemical characterization fit into the MDR
- Develop a testing strategy for multiple devices
- Plan for future testing needs of materials and finished medical device
- Solve problems that may occur during testing, such as a degraded sample or liquid test articles
Who Should Attend?
- Regulatory Affairs and Quality Assurance Professionals
- Research, Design and Manufacturing Engineers
- Microbiologists and Chemists involved in the evaluation of Medical Devices
- Product Managers, Laboratory Managers
- Process Development and System Engineers
- Toxicologists and Biological Safety Specialists
- Testing professionals that require continuing education for RAPS Certification
- Attendees of NAMSA Course A or B and desire more hands-on experience with chemical characterization
Early Registration through 16 April 2021: 403€ ($450 USD)
Regular Registration beginning 17 April 2021: 493€ ($550 USD)
Agenda- coming soon
Nicolas Martin, Ph.DPrincipal Medical Research Scientist
Dr. Martin joined NAMSA in 2012 and holds an Engineer Degree in General Chemistry from École Supérieure de Chimie Physique Électronique de Lyon (France) and a PhD in Organic Chemistry from the University of Birmingham (UK). His expertise includes organic, analytical and industrial chemistry, material and chemical characterization, with over 8 years’ research laboratory experience.