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DTSTART;TZID=America/Chicago:20241114T110000
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DTSTAMP:20260619T095010
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UID:10000105-1731582000-1731587400@www.pdamidwest.org
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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DTSTART;TZID=America/New_York:20241023T173000
DTEND;TZID=America/New_York:20241023T193000
DTSTAMP:20260619T095010
CREATED:20240915T160438Z
LAST-MODIFIED:20240915T160504Z
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SUMMARY:The Ohio State University - Meet the Professionals Night
DESCRIPTION:PDA Midwest Ohio State University\n\nJoin us for an exclusive chance to engage with professionals in the Life Sciences Industry! This event is perfect for students who are eager to explore the diverse opportunities in this fast-paced and impactful industry. The event will feature four speakers who will share their unique career journeys and the valuable lessons they’ve learned along the way. \nHear firsthand how they navigated their careers\, overcame challenges\, and found success in their respective areas. This event is designed to give you a look into the realities of what life can look like after graduation and how PDA can be a part of that journey! \nAfter the talks\, take part in a networking session where you can ask questions\, connect with professionals\, and explore how their experiences can help shape your own career aspirations. \n  \nAgenda & Venue\n\nEastern Time Zone\n\n\n\nActivity\nTime (EDT)\n\n\nWelcome to the PDA Midwest Chapter\n5:30 pm – 5:45 pm\n\n\nSpeakers\n5:45 pm ~ 7:05 pm\n\n\nClosing and Networking\n7:05 pm ~ 7:30 pm\n\n\n\n\nLocation\nThe Ohio State University \nRiffe Building – Classroom 112/118\n469 W 12th Ave. \nColumbus\, OH 43123\n \n \nAddmission\n\nFree Admission –  Registration is Needed\n\n  \nspecial thank you to Annual Sponsors!
URL:https://www.pdamidwest.org/event/the-ohio-state-university-meet-the-professionals-night/
LOCATION:The Ohio State University\, 469 W 12th ave.\, columbus\, OH\, 43210\, United States
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DTSTART;VALUE=DATE:20241015
DTEND;VALUE=DATE:20241017
DTSTAMP:20260619T095010
CREATED:20240802T160838Z
LAST-MODIFIED:20241014T013250Z
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SUMMARY:Sterility Assurance & Quality Risk Management
DESCRIPTION: \nPda midwest event\n\nThe PDA Midwest Chapter is excited to announce its continued partnership with the Hyatt Place in Downtown Indianapolis\, IN\, for our second Signature Events: The Sterility Assurance & Quality Risk Management Conference. \nsterility assurance & quality risk management conference\n\nMark your calendars for Tuesday\, October 15th\, and Wednesday\, October 16th\, to engage in a series of insightful presentations.  These sessions will delve into opportunities and case studies related to Sterility Assurance & Quality Risk Management\, presented by industry experts.  Topics will include Quality Risk Management\, Facility Contamination Control\, Endotoxin Testing\, Laboratory Automation\, Terminal Sterilization\, Sterility Assurance\, and more. \nDuring refreshment breaks\, attendees can explore tabletop exhibits\, fostering peer-to-peer discussions and showcasing exhibitors. Plus\, don’t miss the chance to win raffle prizes after the afternoon break! \nagenda & venue\n\nCurrent Presentations & Speakers\n \n \n \n \nHyatt Place – Indianapolis \n\n \n\n130 South Pennsylvania Street\nIndianapolis\, IN 46204\nRoom Rates \nReserved through PDA Midwest for $175 / Night  \n\nRegistration & sponsorship opportunity\n\nRegistration includes*: Admission to networking/cocktail reception & full event access\n *Bronze registration includes commercial slide at the beginning of the conference and recognition in emails only\, admission to event is separate\n\nThank you ALL sponsors\n\nAnnual:\n  \nEvent: Sponsorship Opportunities
URL:https://www.pdamidwest.org/event/sterility-assurance-quality-risk-management/
LOCATION:Hyatt Place Indianapolis\, 130 S Pennsylvania Street\, Indianapolis\, IN\, 46204\, United States
ORGANIZER;CN="Fred Ayers":MAILTO:fayers@valsource.com
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DTSTART;TZID=America/Chicago:20240918T180000
DTEND;TZID=America/Chicago:20240918T203000
DTSTAMP:20260619T095010
CREATED:20240715T202943Z
LAST-MODIFIED:20240918T170604Z
UID:10000102-1726682400-1726691400@www.pdamidwest.org
SUMMARY:PDA MIDWEST- 2024 OHIO EVENT
DESCRIPTION:PDA Midwest OHIO Event\n\nWhat could be better than PDA Midwest\, ATMP’s\, and Pizza in Ohio?\nMark your calendars for Wednesday\, September 18\, 2024\, and join PDA Midwest for a great evening in Ohio. The event will feature networking opportunities\, a discussion on Contamination Control Strategies for ATMP manufacturing\, and a tour of Forge Biologics’ state-of-the-art facility. \n  \nAgenda & Venue\n\nEastern Time Zone\n\n\n\nActivity\nTime (EDT)\n\n\nNetworking with pizza and beverages served\n6:00 pm – 6:45 pm\n\n\nCCS Presentation  – Fred Ayers\, Senior Consultant with ValSource\n6:45 pm ~ 7:15 pm\n\n\nPanel Q&A featuring representatives from Forge Biologics & Andelyn Biosciences\n7:15 pm ~ 7:45 pm\n\n\nFacility Tours\n7:45 pm – 8:30 pm\n\n\n\n\nLocation\nForge Biologics\n3900 Gantz Road\nGrove City\, OH 43123 \n \n \nTickets\n\nPricing is $25 for General Admission\n\n  \nA special thank you to forge biologics for hosting this event!
URL:https://www.pdamidwest.org/event/pda-midwest-2024-ohio-event/
LOCATION:Forge Biologics\, 3900 Gantz Road\, Grove City\, OH\, 43123
ORGANIZER;CN="Jason Willett":MAILTO:jwillett@sterile.com
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DTSTART;TZID=America/Chicago:20240808T110000
DTEND;TZID=America/Chicago:20240808T123000
DTSTAMP:20260619T095010
CREATED:20240621T170838Z
LAST-MODIFIED:20240802T161023Z
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SUMMARY:PDA Midwest/Missouri Valley Joint Virtual Event: Sterilization Conversion
DESCRIPTION:PDA Midwest/Missouri Valley Joint FREE Virtual Event: \nSterilization Conversion \nThe PDA Midwest and the Missouri Valley Chapters are pleased to present two speakers for our August 2024 event to focus on topics related to the medical device sterilization conversions to X-Ray sterilization from Gamma sterilization. \n\n\nPresentations\n\nSpeakers:  \nDr. Samuel Dorey\, Principal Scientist\, Materials & Irradiations Product Development\, Sartorius  \nFlorent Kuntz\, Strategic Development Manager\, Aerial \nTitle: X-Ray Sterilization Conversions \nAbstract: Case study presentation of a Gamma to X-Ray for sterilization conversion\, which discusses testing performed\, Dtser\, Dmax\, activation\, dosimetry and Monte Carlo simulation. \n\nSpeaker: Betty Howard\, Senior Radiation Sterilization Manager\, Steris Corporation \nTitle: Gamma to X-ray Conversions for sterilization of Healthcare Products \nAbstract: Sterilization of healthcare products are well documented with Radiation Technologies (Gamma X-ray and E Beam). Significant guidance is available in published standards\, seminars and other publications that make validation of dose\, and in most cases easy to document and support. The most widely used historically has been gamma with a smaller percentage of E Beam. As processing capacity needs grow and assurance of supplies of critical products are under pressure\, X-ray has become a greater consideration. X-ray has long been an option\, but access globally was not always available. As availability is growing\, we will discuss why X-ray is a viable alternative or addition to a sterilization portfolio\, show how gamma and X-ray compare (similarities and differences)\, and the basics of how converting from gamma to X-ray is achieved.\n \nPresentation Date / Time and Agenda\n\nThursday\, August 8\, 2024 @ 11:00am (Central time zone) \n11:00 AM      Opening/Event Overview \n11:05 AM      Sponsor Video \n11:07 AM      Presentation 1 \n11:37 AM:     Question and Answer Session for Speaker 1 \n11:52 AM      Presentation 2 \n12:12 PM:     Question and Answer Session for Speaker 2 \n12:28 PM      Closing remarks / upcoming events \nsponsorship opportunity\n\n  \nNamePriceBuy\nregistration\n\nWebinar registration is FREE: Thank you to our sponsor!
URL:https://www.pdamidwest.org/event/midwest_missouri/
LOCATION:Virtual Presentation
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