Date(s) - 06/16/2020 - 06/17/2020
1:00 pm - 4:30 pm CET
*** VIRTUAL TRAINING ***
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 19003-18:2020 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 these online sessions, NAMSA will discuss the chemical characterization of materials and the evaluation steps to choose proper tests, extracts and test duration to meet the latest industry requirements. This workshop, split over two (2) half days, 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 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
- Solve problems that might come about in a testing situation such as a degraded sample or liquid test article
- Plan for future testing needs of materials and finished medical devices
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 22 May 2020: 403€ ($450 USD)
Regular Registration beginning 23 May 2020: 493€ ($550 USD)
|Don Pohl, Principal Product Development Strategist, holds a Bachelor’s degree from Ohio State University. Don has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.|