Use of QRM in a Cell & Gene Therapy Clean Room Contamination Control

About the Webinar
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 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.
About Jim Polarine
Jim is a senior technical service manager at STERIS Corporation. Jim is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators with FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST.
About Dan Klein
Dan Klein currently holds the position of Senior Technical Service Manager at STERIS Corporation and has extensive experience in the antimicrobials industry. He has authored numerous articles and several book chapters in peer reviewed journals including the recent chapter on “Disinfectant Efficacy Testing” in Block’s Disinfection, Sterilization and Preservation. He is listed as a co-inventor on multiple United States patents. Dan served as the Chairperson of AOAC International's Committee M on Antimicrobial Efficacy Testing and remains active in multiple industry and standards setting efforts