<< Previous article
RSSL Webinar: Invest...
Next article > >
Setting Shelf-Life: ...

Investigations Bootcamp: Particulate and Microbial Investigations Workshop 

: 8 Jun 2020 - 9 Jun 2020

: Cambridge, United States

Sector: Pharmaceutical

Type: Training


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
Venue

Cambridge
MA
United States


Organizer

Microrite, Inc.
Phone: +[1] 408.445.0507
Email: info@microrite.com
Visit: http://www.microrite.com/mainpage


<< Previous article
RSSL Webinar: Invest...
Next article > >
Setting Shelf-Life: ...