Environmental monitoring is a useful tool to demonstrate the state of control of the facility, but it is not a measure of the finished product quality. This presentation will focus on how to use the EM data appropriately as part of a contamination control plan. It will explain the requirements of Regulatory requirements as per USP, FDA, EU and EMEA. Along with Scott Sutton will discuss how to Design and Manage a Microbiological Monitoring Program. What are the components of and the execution of The Contamination Control Plan will be discussed.
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