Course offering number:1205-204
Course ID:
719
Safety Assessment and Biocompatibility Evaluation
May 7-9, 2012
New Brunswick, NJ
Who Should Attend
This course is intended for professionals who have
responsibilities for the safety and marketing approval of
medical devices and drug/device combination products. It will
be especially valuable to:
• Scientists
• Engineers
• Biologists
• QA/QC
• Manufacturing personnel
• Regulatory affairs
These individuals may come from industrial, government,
academic and/or contract testing facilities. The course should
be especially useful for those newly assigned to product
safety responsibilities although it also provides an opportunity
for more experienced personnel to update their knowledge.
Description
The aim of this course is to review the principles of testing
materials for biocompatibility. The full range of test methods
will be discussed including chemical analysis, cell culture and
other in vitro methods, acute animal studies including USP
methods, thromboresistance, sensitization, long-term implant
and other special studies. The nature of polymers and the
sources of incompatibility will be discussed along with specific
examples. Methods of testing will be related to the end use
of a product. Examples of recommended testing programs
will be presented, as well as the impact of FDA’s Good
Laboratory Practice regulations and ISO requirements on
preclinical testing of materials and medical devices.