Changing the Paradigm: Moving to In-Process Release Testing

05th February 2021 | 10:00am EST | Presented by Scott Weiss, Director, Industrial Microbiology at Johnson & Johnson |BOOK FREE SEAT FOR THIS WEBINAR

Changing the paradigm – moving to in-process release testing is a presentation to explore the possibilities of the future.  We will discuss limitations of traditional methods of monitoring and release, and investigate the existing challenges of current rapid method technologies.  What are we missing?  If we change our way of thinking around the acceptable limitations of traditional methods and look to the future with existing technologies and those on the horizon, using an end-to-end mindset, we can build the better mouse trap within our processes.  We can identify key markers with real time monitoring, using big data, so that by the end of the manufacturing process there is no need for final product microbiological quality testing.

Presented by Scott Weiss, Director, Industrial Microbiology at Johnson & Johnson

Scott Weiss is the Director, Industrial Microbiology at J&J Microbiological Quality & Sterility Assurance (MQSA) and is responsible for supporting microbiological quality for products and processes across Johnson & Johnson.  Scott is a member of the J&J MQSA Leadership Team and a Co-lead for the J&J Industrial Microbiology Council.

Scott Weiss has 20+ years’ experience in sterilization and industrial microbiology.  His span in sterilization includes cycle development, validation and routine control of steam, dry heat, vaporized hydrogen peroxide, ethylene oxide, gamma, e-beam, x-ray and liquid chemical processes.  He has worked on facility design and remediation for clean room / controlled environment, water systems and compressed gases.

He has served as a trainer to the FDA for Ethlyene Oxide use and calculations for reduced gas consumption without impacting product Sterility Assurance Levels, as well as microbiological methods for bioburden analysis.  Scott currently is a member of multiple cross-company industry consortiums, AAMI, and presently leads the Environmental Monitoring Task Force for the PDA.

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