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 and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux |WATCH FOR FREE
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.
Followed by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
Lori Daane is the Director of Scientific Affairs at bioMérieux and has over 30 years’ experience in clinical, environmental and industrial microbiology. She is a technical expert on rapid and alternative methods and provides scientific support to the Healthcare Business in North America. Prior to joining bioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles including VP of Scientific Affairs and Reagent Development. Lori received her Ph.D. from the University of Minnesota in Microbial Ecology and performed postdoctoral research at Rutgers University and Los Alamos National Laboratory. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.
Sponsored by BioMérieux
With more than 50 years of pioneering diagnostics, the people of bioMérieux understand the challenges you face when it comes to ensuring product quality and are proud to offer the most comprehensive portfolio of solutions for microbiology Quality Control of biopharmaceuticals and ATMPs. Choosing the right microbiology diagnostic can boost efficiency with in-processes testing and automation simplifies the testing processes, reduces human error and helps ensures data integrity. Rapid, simple, at-line testing of key parameters with allows in-process tests to be performed closer to the production environment and provide certainty that your manufacturing process is secure.