COURSE A: Biocompatibility of Medical Devices: Two Day Certification Course - Friday, August 31, 2012
This course is geared toward those who need to have a working knowledge of biocompatibility. The objective of the course is to teach participants how to use standards to establish a biological safety evaluation plan. Participants also learn how to document and implement their plan. Use of risk assessment is covered and participants will practice evaluating biological risk. Both days are structured to be hands-on. Participants must attend and complete all exercises to be certified as a biological safety specialist.
- ISO 10993-1 and the FDA G-95 memorandum. Know how to use the ISO documents to locate information that you need.
- Materials characterization, but more importantly learn how to use the information to understand biological safety.
- ISO 14971 and how to use it. Learn how to use ISO 10993-1 as a tool for hazard identification.
- Distinguish the difference between evaluation and testing. Recognize when testing is absolutely necessary.
- Tests to select and how to choose among various options. Understand when testing is not the only option.
- Develop a program that guides your device on the regulatory path and reduces your time to market. Topics addressed include principles of toxicology, FDA consensus standards, and Good Laboratory Practices.
- Execute your plan from development to completion and how to schedule and document the implementation of your biocompatibility plan.
Upcoming Event Dates:
June 3-4, Brussels, Belgium
July 8-9, Philadelphia, PA
Check the registration page for course availability.