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SUMMARY:PDA Midwest Webinar: Radiopharma 101-An Introduction to Radiopharmaceuticals
DESCRIPTION:Radiopharma 101: An Introduction to Radiopharmaceuticals\n\n\n  \n\nHosted by the PDA Midwest Purdue Student Chapter\n\nOpen to All Students\nRadiopharmaceuticals are at the forefront of innovation in modern medicine—combining radioactive isotopes with biologically active molecules to diagnose\, monitor\, and treat disease. While nuclear medicine has been practiced for decades\, recent advances in targeted radionuclide therapies and theragnostic platforms have driven significant industry growth and renewed global investment. This rapid evolution has also increased regulatory focus worldwide.\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nAbout the Presentation\n\nRadiopharma 101 provides a foundational overview of the radiopharmaceutical field\, designed for students interested in pharmaceutical science\, engineering\, microbiology\, quality\, manufacturing\, and regulatory affairs. \nThis presentation will explore: \n\nThe history and evolution of nuclear medicine\nMajor classes of diagnostic and therapeutic radiopharmaceuticals\nEmerging theranostic platforms and the diseases they target\nHow and where radiopharmaceuticals are manufactured\nThe unique challenges of producing time‑sensitive radioactive medicines\nAn overview of global regulatory expectations governing this rapidly growing industry\n\nAttendees will gain valuable insight into a specialized and expanding sector of pharmaceuticals\, making this session ideal for students considering careers in advanced therapies\, sterile manufacturing\, or regulatory science. \n  \nSpeaker\n\nKim Sobien\nSenior Microbiology Consultant\, ValSource\, Inc. \nKim brings over 25 years of pharmaceutical industry experience\, with deep expertise in microbiology\, sterility assurance\, contamination control\, aseptic processing\, investigations\, and inspection readiness. Her career spans a wide range of injectable products\, including radiopharmaceuticals\, biologics\, contract manufacturing\, and pre‑filled syringe generics. \nShe holds a BS in Microbiology from the University of Wisconsin–La Crosse and an MBA in Global Management from the University of Phoenix. Kim is an active leader within the Parenteral Drug Association (PDA)\, serving as: \n\nPresident‑Elect\, PDA Southeast Chapter\nCo‑Lead\, PDA EM/Microbiology Interest Group\nFormer Co‑Chair and Committee Member\, PDA Pharmaceutical Microbiology Conference\n\n  \nEvent Details\n\n\nDate: April 22\, 2026\nTime: 6:30 PM – 7:30 PM (EST)\nFormat: Live virtual webinar (Microsoft Teams)\nAudience: Open to all students\n\n\n\n\nRegistration\n\nWebinar registration is FREE\n\nRegister Now \n 
URL:https://www.pdamidwest.org/event/pda-midwest-webinar-radiopharma/
LOCATION:Virtual Presentation
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DTSTART;TZID=America/Chicago:20251216T103000
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DTSTAMP:20260610T021200
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SUMMARY:PDA Midwest Webinar: Advocating for Access – A Conversation with Angels for Change
DESCRIPTION:Advocating for Access – A Conversation with Angels for Changes\nJoin us for an inspiring and informative webinar featuring Laura Bray and Anthony Flammia\, leaders from Angels for Change\, a nonprofit organization committed to eliminating drug shortages and championing patient advocacy. During this session\, you’ll gain a deeper understanding of their mission to ensure equitable access to essential medications\, hear real-world stories that highlight the impact of their work on patients and healthcare systems\, and discover practical ways you can contribute to driving meaningful change. The event will include a comprehensive presentation followed by an interactive Q&A\, offering you the opportunity to engage directly with experts and explore solutions that make a difference in healthcare access.\n\n  \nPresentation Date and Time\n\nTuesday\, December 16\, 2025 from 10:30am to 11:45am (Central time zone) \n  \nPresentation\n\n  \nAdvocating for Access: Ending Drug Shortages Together \n\nDiscover how Angels for Change partners with patients\, healthcare providers\, and manufacturers to combat drug shortages and guarantee timely access to critical\, lifesaving medications. \n  \nFeatured Presenters: \n\nLaura Bray – Founder & CEO\, Angels for Change\nAnthony Flammia – Director of Advocacy\, Angels for Change\n\n \n\nRegistration\n\nWebinar registration is FREE\n\nRegister Now \n 
URL:https://www.pdamidwest.org/event/pda-midwest-webinar-advocating-for-access-a-conversation-with-angels-for-change/
LOCATION:Virtual Presentation
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DTSTART;TZID=America/Chicago:20241114T110000
DTEND;TZID=America/Chicago:20241114T123000
DTSTAMP:20260610T021200
CREATED:20241029T203317Z
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SUMMARY:Digital Enhancements for Pharma Operational Excellence
DESCRIPTION:Digital Enhancements for Pharma Operational Excellence\n\nIn 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. \n-Presented by Roger Ouimet\, CAI and Nick Armstrong\, Digital Enablement \n\n  \nPresentation Date and Time\n\n\nThursday\, November 14\, 2024 @ 11:00am (Central time zone)\n\n  \nPresenters – Bio\n\nRoger Ouimet\, Principal Consultant CAI:\nRoger 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.   \n\n  \nNick Armstrong\, Senior Director of Digital Enablement:\nNick 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. \n\n  \nRegistration\n\nWebinar registration is FREE\n  \n\nRegister Now \n 
URL:https://www.pdamidwest.org/event/enhancing-operational-readiness-using-ai-technology/
LOCATION:Virtual Presentation
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