Date/TimeDate(s) - May 19, 2022
09:00 AM - 03:45 PM CT
Date: May 19, 2022
Location: Virtual Training
Time: 9:00 am – 3:45 pm Central Standard Time (U.S.)
Pricing: Early Registration through March 31, 2022: $500 USD
Regular Registration beginning April 14, 2022: $600 USD
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.
There are several potential nuances medical device manufacturers must understand when applying ISO 10993-18: 2020. For example, Notified Bodies may require additional evaluation to meet the requirements of the EU’s Medical Device Regulation (MDR), 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 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 and 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 ISO 10993-18:2020 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
NOTE: If you are working from home during this time, please ensure to include your home address under the shipping field during registration. Course materials will be shipped to the shipping address you provide.
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ISO 10993-18:2020 Chemical Characterization Of Materials Workshop— Virtual (US time zone)
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Agenda- coming soon
Don PohlPrincipal Product Development Strategist
Don holds a Bachelor’s degree from Ohio State University and 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.