LAST CHANCE TO REGISTER
Workshop Series
A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom
18 Nov 2021 | 9.30-11.00am 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:
 
  • Validation Managers
  • Quality Control Managers
  • Quality Assurance Managers
  • Lean Managers
  • Operations Managers
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers
Led by:
Jim Polarine Jr
Senior Technical Service Manager, STERIS Corporation

With STERIS Corporation for 20 years, Jim’s current technical focus is microbial control in cleanrooms and other critical environments. A frequent industry speaker, he has published several PDA book chapters and articles related to cleaning and disinfection and contamination control. Active on PDA’s COVID-19 and Microbial Excursions Task Forces, Jim co-authored PDA’s Technical Report #70 on Cleaning and Disinfection. He teaches regulators from FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries. Jim is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST.
Dan Klein
Senior Technical Service Manager, STERIS Corporation

Dan has extensive experience in the antimicrobials industry, including over 20 years as R&D Manager of Microbiology and Clinical affairs and management of a contract testing laboratory. His technical expertise includes supporting multiple areas including pharmaceutical, healthcare and Department of Defense applications.
He has authored articles and several book chapters in peer reviewed journals. most recently “Disinfectant Efficacy Testing” in Block’s Disinfection, Sterilization and Preservation. Dan served as the Chairperson of AOAC International's Committee M on Antimicrobial Efficacy Testing and is listed as co-inventor on multiple US patents. He holds a BSc in Microbiology from the University of Illinois and MA in Biology from Washington University.  
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