Digital Enhancements for Pharma Operational Excellence
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Digital Enhancements for Pharma Operational Excellence
In this talk, we will explore how cutting-edge generative AI technologies are driving operational excellence in the pharmaceutical industry. Through real-world examples, we’ll discuss how large language models (LLMs) are automating summary documentation in commissioning testing, drastically improving efficiency and reducing human error. We’ll dive into how GraphRAG is uncovering hidden trends and relationships in quality documentation, enabling better decision-making and continuous improvement. Finally, we’ll look at how large vision models and reality capture technology are transforming physical plants into fully contextualized digital replicas, revolutionizing how facilities are managed and maintained. This is the future of pharma operations, where AI not only enhances productivity but also drives a new standard of operational excellence.
-Presented by Roger Ouimet, CAI and Nick Armstrong, Digital Enablement
Presentation Date and Time
Thursday, November 14, 2024 @ 11:00am (Central time zone)
Presenters – Bio
Roger Ouimet, Principal Consultant CAI:
Roger is an experienced Program Manager and Owner Project Manager, with extensive background in implementing small to large-scale expansion capital projects in Formulation, Filling, Packaging and QC Labs, as well as across entire facilities for New Product Introduction and the associated Commissioning, Qualification, and Validation (CQV) deliverables and processes to support planning and execution. Additionally, Roger spent 30 years Active and Reserve in the US Navy, filling seven Command and additional unit, staff and global leadership roles. As a Principal Consultant and Interim Director, Program and Project Management, he has launched QC Applications, Manufacturing Execution System (MES) upgrades, and a vial powder filling isolator product and process. He also delivered a new Project Management Office (PMO) and Operational Excellence programs for his clients. An active member of several PDA Interest Groups, Roger contributed comments to the FDA and EMA on their draft guidance papers on AI in Drug Development and Drug Manufacturing, and the Department of Homeland Defense’s draft law on Cyber Incident Reporting for Covered Entities.
Nick Armstrong, Senior Director of Digital Enablement:
Nick is a seasoned leader with 15 years of experience as a process and reliability engineer in the pharmaceutical manufacturing industry. As Senior Director of Digital Enablement at CAI, he leads the integration of advanced technologies like AI, digital twin, and augmented reality to enhance project delivery and drive operational excellence. He also spearheads research initiatives with external partners to push innovation in these areas. In addition, Nick serves as Co-Chair/Founder of the ISPE Artificial Intelligence Community of Practice, where they help educate 22,000 members on the applications of AI in life sciences and contribute to shaping industry guidelines for regulatory bodies like the FDA and EU regulators.
Registration
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