Microbial and particulate contamination has many consequences; patient harm, failed media fills, inconclusive investigations and continuing contamination events are frequently associated with voluntary or involuntary plant shutdowns, product recalls, and warning letters.

This comprehensive two-day course on investigation of microbial and particulate contamination in cleanrooms, manufacturing processes, laboratory testing, and product will provide the tools for conducting in-depth, fact-based and scientifically sound investigations.

Overview

• Particulate contamination in cleanrooms and barrier systems
• Particulate contamination in products
• Why validate microbial identification results
• Investigating mold contaminations
• Investigating environmental monitoring excursions
• Investigating sterility test and media fill failures
• Investigation of microbiological out of specification (OOS) results
• Documenting investigations
• Assessing risk to patient-the main reason for investigations