Date/TimeDate(s) - November 23, 2021
09:00 AM - 03:45 PM GMT
LocationSteigenberger Hotel Metropolitan
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 in-person 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 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 30 September 2021: 403€ ($450 USD)
Regular Registration beginning 1 October 2021: 493€ ($550 USD)
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Register Your Attendance
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Agenda- coming soon
Alfred Dibao-Dina, Ph.DBiological Safety Specialist
Alfred Dibao-Dina holds a Ph.D. degree in Biomedical Engineering. At NAMSA since 2017, he started as a Technical Advisor by providing technical and regulatory guidance to medical device’s manufacturers through preparation of quotes for consulting and testing services compliant with the international standards. His current role at NAMSA as a Biological Safety Specialist focuses on the redaction of Toxicological Risk Assessments per ISO 10993-17 and Biological Risk Assessments per ISO 10993-1 and ISO 14971. He is knowledgeable in evaluating the biocompatibility of medical devices according to the ISO 10993 series and provides regular internal and external trainings in chemical characterization according to ISO 10993:18.