This seminar will cover a risk-based approach to an Aspergillus brasiliensis and Chaetomium contamination in a Cell and Gene Therapy Cleanroom.  

 

Details will be provided on:

  1. How to follow a risk-based approach utilizing a fishbone diagram and the five whys centered on using good science.  
  2. The most common causes of contamination, in case studies with fungal spore contamination.  
  3. New efficacy testing data on Chaetomium and Aspergillus.  
  4. A recent case study as well as microbial identifications and how to utilize a risk-based approach.  
  5. Solutions on how to proactively prevent fungal contamination from reoccurring.

Led by STERIS Expert:

1) Jim Polarine Jr. MA., Senior Technical Service Manager, STERIS Corporation

1) Dan Klein, Senior Technical Service Manager, STERIS Corporation