Environmental Monitoring and the Contamination Control Plan

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.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies (Pharma, medical device, biotech, OTC etc) that need to the employees who will benefit include:

• End-users responsible for finished product testing
• QA managers and personnel
• Consultants
• Quality system auditors

Instructor Profile:
Scott Sutton, Dr. Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). After a NIH postdoctoral fellowship he worked for Bausch and Lomb until 1994 when he went to Alcon Laboratories, and in 2004 accepted a position with Vectech Pharmaceutical Consultants. He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000. Dr. Sutton also operates an information source on the internet, The Microbiology Network (http://www.microbiol.org) which provides services to microbiology-related user’s groups and supports the PMFList, a microbiology Email list (http://www.microbiol.org/pmflist.htm) and the PSDG Email list (pharmaceutical stability topics) (http://www.microbiol.org/psdglist.htm).

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