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Full description:

Why Should You Attend: 

The industry has seen an increase in the number and species of bacterial endospores and mold spores found in their facilities. This presentation will focus on ways to limit bacterial and mold spore contamination from incoming items into cleanrooms and limit other sources of spore contamination. Sporicidal products will be discussed and data will be presented which can be used to address bacterial spore issues. Current industry regulation in the US and Europe will be discussed related to sporicides.

This presentation will convey a robust approach to addressing bacterial spores by covering personnel practices, incoming items into cleanrooms, facility design and conditions, and the products used to address bacterial and mold spores as well as more resistant bacterial spore species. The audience will get a flavor of the current issues in the industry with bacterial spore outbreaks and develop a better understanding of how to prevent outbreaks. The audience will also see sporicidal data and hear industry experiences which will allow them to better address contamination control programs. The presentation will provide troubleshooting skills and experiences for bacterial spore contamination issues.

Intended audience:

• 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
• Production Managers
• Cleanroom Operators

What you will learn:

• Developing effective ways to address spore excursions.
• Troubleshooting real world experiences.
• Developing preventative action plans.
• Learn ways to improve facility design and maintenance.
• The most effective sporicidal chemistries will be discussed in detail.
• Cleaning and Disinfection Methods will be addressed.
• Warning Letters and 483’s from FDA will be discussed and addressed.