Package Validation Requirements for Medical Devices and Combinatory Products Seminar

Package Validation Requirements for Medical Devices and Combinatory Products Seminar

FDA concerns regarding terminally sterilized medical products are based on years of data that implicates failures in primary packaging. The majority of failures occur because of inadequate package validation programs.

This seminar will detail the general concepts and problems associated with medical device packaging testing as well as reviewing different testing methodologies. In addition, we will outline the necessary sterilization processes and test methods that should be part of any reliable validation program. Specific topics will include:

ISO 11607 Overview
Physical Package tests vs Microbial
Stability & Accelerated Aging
Combinatory Products
Flexible Packaging
ISTA Shipping Testing

Where:	Microtest Laboratories, Inc.
Date:	Wednesday, November 12, 2008
Time:	10:00 a.m. - 1:00 p.m
Location:	104 Gold Street Agawam, MA 01001

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For more information, call toll-free 1-800-631-1680

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