Corrosion Testing of Medical Devices: Proving Biocompatibility from Medical Device Daily When: Thursday, November 6, 2008 Time: 1pm to 2:30pm ET Cost: $349 per listening site no. Speakers: Dr. Shari Rosenbloom and Dr. Esra Kus Duration: 90 Minutes 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 the 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 or Questions 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 the FDA views test results — understanding what the FDA is looking for

Target Audience: QA/QC professionals Manufacturing directors, supervisors and staff Anyone responsible for implantable device testing Level: Advanced Registration includes admittance to the 90-minute call for as many people as you can fit in a room with a speakerphone. Access to the specially created presentation handouts (available 48 hours in advance). Participation in the 30-minute, live Q&A with the speaker following the presentation. Certificates of attendance for all audio conference attendees. Click here to register. If you prefer to register, or order the CD recording (MP3 format) by phone, then call us at 800-688-2421 or 1-404-262-5474.