Solutions for addressing microbial excursions in Medical device, Pharmaceutical, and Biotech industries

Why Should You Attend:
The most common sources for microbial excursion are personnel practices, cleaning and disinfection program, facility design and conditions, and bringing items into the clean room. This webinar will discuss the details of specific excursion investigation for outbreaks of molds, vegetative bacteria, and Bacillus. End users will gain a new understanding of the complexity of troubleshooting outbreaks and contamination issues based on real life experiences.

Case Studies will be discussed and reviewed involving bacterial and fungal outbreaks in clean room operations. Contamination Control strategies will be reviewed and discussed in detail. Real world scenarios will be discussed from best practices in contamination control perspective.

Areas Covered in the Seminar:

• Review data from “real-world” examples.
• Learn how to develop solutions to your microbial control problems.
• Learn both the preventative measures and corrective actions.
• What are the best Practices in contamination prevention.
• Recent outbreaks of fungal excursions will be discussed and studied.
• Guidance to identify and rectify Cleaning and Disinfection, Personnel Practices, and Facility Design Flaws.

Who Will Benefit:

This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs, including companies in the Pharmaceutical, Biotech, and Medical Device fields:

• QA and QC Managers
• Disinfectant Validation Managers
• Operations Managers
• Cleanroom Managers
• Personnel and contractors that clean and disinfect cleanrooms
• Regulatory Compliance Managers & Environmental Monitoring Managers

Instructor Profile:
Jim Polarine, is a technical service specialist at STERIS Corporation. He has been with STERIS Corporation for over eight years, where his current technical focus is microbial control in Cleanrooms and other critical environments. He has lectured in North America, Europe, Asia, Latin America, and Puerto Rico on issues related to disinfection and sanitation in Cleanrooms. Mr. Polarine is a frequent industry speaker and has worked on several book article publications related to cleaning and disinfection and contamination control. He is currently co-authoring several articles and is an author on the PDA technical report on cleaning and disinfection. He is also currently active on the PDA task force on cleaning and disinfection. He has presented at key industry events for PDA, ISPE, AALAS, IVT, University of Tennessee, SWE, and Barnett International on cleaning and disinfection and contamination control.

Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology, and is a member of the PDA, ISPE, IEST, ASM, AALAS, ASTM, AAAS, AOAC, and ACS. He previously worked as a clinical research coordinator with the Department of Veterans Affairs and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and safety.

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