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. Areas Covered in the seminar: * Regulatory Expectations for EM will be examined using guidance from US, Europe and PIC/S.
* Cleaning/Disinfection must be validated, and then shown to be effective on an on-going basis.The EM program can be used effectively to demonstrate the adequacy of the sanitization schedule.
* The Contamination Control Plan might be the single most important document never written. While this is sometimes present as the "Sterility Assurance" plan, more often no comprehensive plan exists for the facility.Components of the document and its execution will be addressed.
* Designing and Managing a Microbiological Monitoring Program - this will include surface, active air, passive air, utilities and personnel monitoring.
* Considerations in Trending EM Data - suggestions on different types of trending approaches will be provided.