By : Compliance Online
Date : 2012
Location : United States US / Palo Alto
This 90-minute cleanroom contamination control training will review the common mistakes that people make in cleanrooms that lead to contamination, show how to develop a successful contamination control program and discuss ways to improve your facility's design and maintenance.
Environmental Monitoring, Contamination Control, Cleanroom cleaning, disinfection, facility design, Pharma training
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.
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
- Quality system auditors
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.
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).
Recorded webinar and reference materials will be available on your account after purchase.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria