Date(s) - 09/11/2019
9:30 am - 3:45 pm GMT+2
Prior the release of 10993-1 in 2009, chemical and material characterization of materials and devices (ISO 10993-18) had always been an important step in biological safety evaluation. Now, as the U.S. Food & Drug Administration (FDA) places increased emphasis on characterization, as outlined in their 2016 guidance document, EU Notified Bodies are now also requesting additional evaluation as the Medical Device Regulation (MDR) looms closer.
These requirements can become even more confusing when other comments and expectations are presented from varying global regulatory agencies, making it more important than ever to understand evaluation principles and their role in the evaluation continuum.
In this session, NAMSA will discuss the chemical characterization of materials and the evaluation steps to choose proper tests, extracts and test duration. This one day workshop will include class led instruction, as well as multiple hands-on exercises for attendees to learn while being guided by experienced NAMSA instructors.
Learning will be provided that will allow attendees to:
• Relate ISO 10993-18 to ISO 10993-1 and the biological evaluation of devices
• Discuss upcoming changes to ISO 10993-18 and your testing strategies
• 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 31 July 2019: 350€ ($400 USD)
Regular Registration beginning 1 August 2019: 450€ ($500 USD)
|Overview of ISO 10993-18||10:00-11:00 AM|
|Workshop||11:15 AM-12:00 PM|
|Tests to Consider||13:00-14:00 PM|
Ramona Polexe is Technical Advisor Manager in Europe specializing in Analytical Chemistry, Biocompatibility and Biological Safety at NAMSA.
She has a PhD in Physico - Chemistry applied to pharmaceuticals and materials sciences, and a Master in Physico –Chemistry of Materials, both from the University of Montpellier( France).
During her career, she has held positions as : research scientist in biopolymers materials, R&D project manager, and lead her own innovative medical device business project. She has spoken and published in several conferences and international newspapers.