Thursday May 2, 2024
12:00 Noon – 1:30 pm (NY Time)
Instructor: Jim Polarine
Abstract:
This seminar will cover a risk-based approach to an Aspergillus brasiliensis 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 will be conveyed in case studies with fungal spore contamination. New efficacy testing data will be covered on Chaetomium and Aspergillus. A recent case study will be covered in detail as well as microbial identifications and how to utilize a risk-based approach. Solutions are going to be conveyed 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
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-597