STERIS Workshop: A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom

18 Nov 2021
9.30-11.00 am SGT | Online

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.

Who Should Attend the Webinar:

  • Validation Managers
  • Quality Control Managers
  • Quality Assurance Managers
  • Lean Managers
  • Operations Managers
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers

Session Leaders:

Jim Polarine Jr MA


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


Dan Klein


  Dan Klein, Senior Technical Service Manager, STERIS Corporation


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