Lesson learnt on FDA citations on cleaning, disinfection and sterilization’

About the Webinar
Microbial and product contamination is one of the major challenges faced by manufacturing companies within the GMP regulated industries. These contamination events will lead to production downtime, time spent on investigations, product recalls and risk to patient safety. This presentation will look at the past FDA citations (Warning Letters and 483s) related to cleaning and disinfection, process equipment cleaning and sterilization processes. Valuable lessons can be learnt from these past FDA citations which will enable companies to avoid having similar regulatory citations. In addition, this will also help to minimize the risk of microbial and particle contamination in finished products.
About Presenters
Richard Chai is a Technical Service Manager in the Life Sciences Division of STERIS Corporation. He currently provides global technical support related to process equipment cleaning and contamination control in cleanrooms. Richard has 20 years of pharmaceutical industry experience in manufacturing, validation, consultancy and technical support. He earned a Bachelor Degree in Mechanical and Production Engineering from Nanyang Technological University, Singapore.
Mr. Polarine 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.