Panel Discussion
Wednesday, March 26
05:30 PM - 06:30 PM
Live in San Diego
Less Details
This panel convenes esteemed industry leaders, and MES authorities, to underscore the imperative of Manufacturing Execution Systems (MES) in fortifying compliance, operational efficiency, and data veracity within (GMP) environments. Central to this discourse is the emphasis on strategic planning and the deployment of MES, defining and monitoring successful implementation Key Performance Indicators (KPIs), advocating for a ‘doing it right the first time’ ethos as the cornerstone of any MES project strategy. The conversation will pivot to the strategic design of digital processes to foster reusable elements, thereby expediting organizational scaling and the seamless onboarding of new processes.
Jeremy Tanner is a passionate industry expert for GxP informatics solutions with over 15 years-experience in the pharmaceutical industry. He has managed multiple manufacturing units of varying modalities and driven efficiency improvements by implementing paperless informatics solutions for QC microbiology and then helping to design and develop an MES solution to meet the demands of future manufacturing modalities. In his current role, Director of Sales- Informatics, he interfaces with customers to understand their digitization journey and recommend solutions that can meet their unique needs. He is responsible for the MODA Platform which includes MODA-EM® for QC microbiology, MODA-ES® for manufacturing execution and MODA-eLogs for replacing paper log books.
Jeremy is also a contributing author to Environmental Monitoring: A Comprehensive Handbook, Volume 3.
Nick has been working with MODA-ES in the pharmaceutical industry for over 5 years. Prior to that, he worked as an I&C engineer in the nuclear power industry for 10 years. Nick lives in Charlotte, NC with his wife and two daughters.
David “Joey” Lutskus is a subject matter expert on MES solutions with over 20 years’ experience in the bio-pharmaceutical industry. Currently, IT Head of Cell and Gene COE at Lonza, Joey is responsible for leading all strategic initiatives, along with managing the project teams for the deployment of MODA-ES. The software has been deployed across four (4) Cell and Gene sites and two (2) Drug Product sites within Lonza. Previously, Joey worked in various roles across manufacturing modalities, supporting FormWeigh, SAP and Rockwell’s PharamSuite software. Joey is a member of the BioPhorum IT MES of the Future working team.
Mike Cable is a Level 3 ISA Certified Control System Technician and certified Project Management Professional (PMP). He is currently Program Manager of Facilities, Calibration, and Validation at Benecyte, Inc. in Durham, NC where his responsibilities include managing Operations Technology.
Mike started his career as an Electronics Technician in the Navy Nuclear Power Program, serving as a Reactor Operator and Engineering Watch Supervisor aboard the USS Los Angeles submarine and then at the AIW nuclear prototype in Idaho Falls. After leaving the Navy, he started his civilian career at Performance Solutions performing technical services for the pharmaceutical industry. His 11 years there was highlighted by an assignment to Eli Lilly Corporate Process Automation managing Instrument Qualification projects and then starting up a Calibration Services division within Performance Solutions. Mike has since worked within personalized immunotherapy operations as Validation Manager, Facilities Management and in Operations Technology implementing electronic systems (MODA-EM, MODA-ES, FactoryTalk PharmaSuite, MasterControl, ProCal, SAP, and Sage ERP). Mike has also been a Consultant with PCI in Raleigh helping companies bring value-added improvements to their calibration programs along with implementations of Blue Mountain Regulatory Asset Manager.