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Course Description

Process validation for medical injection molding this seminar will cover the basic requirements for process validation in an FDA-regulated environment. Medical device regulations and QSRS (formerly GMPS) will be explored, including their application to injection molding. Specifically, how the IQ, OQ and PQ concepts are applied to molding processes will be reviewed. The application of doe and statistical process control will also be discussed, including how these tools can assist the molder with showing good validation to their customers or regulators.

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