November 5, 2009
Thompson Interactive is sponsoring a 90-minute audio conference featuring Exponent consultants
Dr. Shari Rosenbloom and Dr. Esra Kus.
Thursday, November 6, 2008
1:00pm to 2:30pm Eastern
Course Description
Before a medical implant device can be sold, the device's manufacturer must demonstrate that the implant will be biocompatible-it must not adversely affect its host environment (the patient's body), nor should it be adversely affected by the environment. Corrosion resistance is a key factor in biocompatibility.
In this 90 minute audio conference, Dr. Shari Rosenbloom and Dr. Esra Kus will examine the types of corrosion most commonly encountered in medical devices. They will review the FDA's guidance on in vitro corrosion testing to provide a better understanding of what the FDA is looking for from device manufacturers in demonstrating corrosion resistance of their devices. They will discuss the various testing methods available, and when each test method should be used. They will show how to design an appropriate testing program, and how to interpret the results of testing. They will also present the lessons learned from experiences with the FDA's response to results submitted from in vitro corrosion testing.
Learning Points To Be Answered:
• Significance of corrosion with regards to device functionality and biocompatibility
• Different types of corrosion that are relevant to medical implants
• Typical medical implant alloys and their corrosion properties
• Perspective on FDA guidance on corrosion
• Overview of corrosion testing methods - what they are, which tests are appropriate (ISO, ASTM standards)
• Interpretation of test results, acceptance criteria, and relationship between in vitro testing and in vivo performance
• Perspective on how FDA views test results - understanding what the FDA is looking for
Enrollment
Just $325 per listening site no matter how many people are in the room!
Please click here to learn more and to register
This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
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