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:
- How to follow a risk-based approach utilizing a fishbone diagram and the five whys centered on using good science.
- The most common causes of contamination, in case studies with fungal spore contamination.
- New efficacy testing data on Chaetomium and Aspergillus.
- A recent case study as well as microbial identifications and how to utilize a risk-based approach.
- 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., Senior Technical Service Manager, STERIS Corporation
Dan Klein, Senior Technical Service Manager, STERIS Corporation
Hosted by:
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