Investigations Bootcamp: Particulate and Microbial Investigations Workshop
: 8 Jun 2020 - 9 Jun 2020
: Cambridge, United States
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.
- 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