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DTSTART;VALUE=DATE:20260513
DTEND;VALUE=DATE:20260515
DTSTAMP:20260526T051204
CREATED:20260306T212604Z
LAST-MODIFIED:20260513T113457Z
UID:10000114-1778630400-1778803199@www.pdamidwest.org
SUMMARY:18th Annual Microbial Contamination and Control Conference
DESCRIPTION:PDA Midwest Event\n\nMicrobial Contamination and Control\nPDA Midwest Chapter is pleased to announce that we will once again partner with the Hilton Chicago Northbrook Hotel in Northbrook\, Illinois for one of our signature events\, the 18th Annual Microbial Contamination and Control Conference. \nJoin industry colleagues\, subject matter experts\, and peers on Wednesday and Thursday\, May 13–14\, for two days of engaging discussion and learning . This conference will feature an agenda packed with thought‑provoking presentations that explore both current expectations and emerging opportunities across the pharmaceutical\, biotechnology\, and medical device industries. \nAttendees can expect in‑depth sessions covering key topics such as Artificial Intelligence\, Environmental Monitoring\, Contamination Control Strategies\, Root Cause Analysis\, and other critical elements of microbial control programs. The program is designed to support practical application\, knowledge sharing\, and meaningful dialogue among professionals responsible for maintaining robust contamination control and sterility assurance systems. \nNetworking is an integral part of this event. Refreshment breaks will feature tabletop exhibits\, providing dedicated time for peer‑to‑peer interaction and opportunities to connect with exhibitors showcasing relevant products and services. To add to the experience\, raffle prizes will be awarded following the Thursday afternoon break. \nWhether you are looking to deepen your technical understanding\, exchange best practices\, or expand your professional network\, the 18th Annual Microbial Contamination and Control Conference offers valuable insights and connections in a collaborative setting. \nAgenda & Venue\n\nAgenda Topics\n  \n  \n \n \n  \n \n  \n  \nVenue\n\n🏨 Special Conference Hotel Rate – $120 per Night\nA special conference room rate of $120 per night has been secured at the Hilton Chicago/Northbrook Hotel exclusively for conference attendees. This convenient on-site lodging offers easy access to all conference activities. Rooms at the conference rate are limited\, so early booking through this link is strongly encouraged. \nReserve Now\n\nLocation\nHilton Chicago/Northbrook\n2855 N. Milwaukee Ave.\nNorthbrook\, IL 60062\n\n \n \n \n\n \nRegistration & sponsorship opportunity\n\nRegistration includes*: Admission to networking/cocktail reception & full event access\n\n *Bronze registration includes commercial slide at the beginning of the conference and recognition in emails \nsponsorship Attributes\n\n \nThank you sponsors\n\n  \n \n  \n  \n  \n 
URL:https://www.pdamidwest.org/event/18th-annual-microbial-contamination-and-control-conference-2/
LOCATION:Hilton Chicago-Northbrook\, 2855 North Milwaukee Ave\, Northbrook\, IL\, 60062\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20260428T170000
DTEND;TZID=America/Chicago:20260428T203000
DTSTAMP:20260526T051204
CREATED:20260127T153000Z
LAST-MODIFIED:20260414T191146Z
UID:10000113-1777395600-1777408200@www.pdamidwest.org
SUMMARY:PDA Midwest Dinner Event: Quantifying EU MDR Sterilization Deficiencies
DESCRIPTION:PDA Midwest Dinner Event – April 28th\, 2026\n\nSterilization Deficiencies\nThe PDA Midwest Chapter is pleased to host our April 2026 dinner event\, featuring an exclusive behind‑the‑scenes laboratory tour and an in‑depth technical presentation at TÜV SÜD in New Brighton\, Minnesota. This unique program offers attendees the opportunity to explore a leading testing and certification facility while gaining firsthand insights into the latest sterilization expectations\, challenges\, and regulatory trends. \nDesigned for professionals across the medical device and pharmaceutical industries\, the event will highlight critical topics in sterilization science and compliance. Participants will learn how evolving regulatory frameworks—particularly under EU MDR and ISO standards—shape sterilization strategies\, documentation requirements\, and submission quality. Whether you are involved in product development\, sterility assurance\, validation\, quality\, regulatory affairs\, or manufacturing\, this event provides valuable knowledge to support robust and compliant sterilization programs \nAgenda & Venue\n\nJoin us on 4/28\, 2026 from 5:00pm – 8:30pm central time zone\n\n\n\nActivity\nTime (CST)\n\n\nRegistration/Networking\n5:00pm – 6:00pm\n\n\nDinner\n6:00pm – 7:00pm\n\n\nLaboratory Tour \n7:00pm – 7:45pm\n\n\nPresentation \n7:45pm – 8:15pm\n\n\nQ&A with Presenter / Closing\n8:15pm – 8:30pm\n\n\n\n\nLocation\nTÜV SÜD Testing Lab\n1141 14th ST NW\nNew Brighton\, MN 55112\n(978) 573-2500\n \nPresentation\n\nSpeaker\n Michael Taylor – Medical Product Expert\, TÜV SÜD\n \nMichael Taylor holds a Master’s degree in Biomedical Engineering from Mercer University and brings extensive experience in medical device sterilization\, technical assessment\, and regulatory compliance. His background includes supporting terminal sterilization processes\, sterility assessments\, and technical documentation reviews for MDR\, MDD\, MDSAP\, and ISO 13485 submissions. \n\n\n  \n  \nPresentation Title\nQuantifying EU MDR Sterilization (EO/IRR) Deficiencies: Lessons Learned\nAbstract \nBiological safety deficiencies in medical device submissions often lead to delays and substantial costs for manufacturers. This presentation delivers a quantitative review of TÜV SÜD‑issued sterilization deficiencies\, focusing on requirements in EU MDR 2017/745 and the ISO 11135/11137 standards. \nThe session will highlight real-world data\, trends by device class\, and common pitfalls\, particularly within EO and irradiation sterilization. Attendees will gain practical guidance to help reduce deficiencies and improve submission quality. \nTopics Covered \n\nCommon Sterilization Deficiencies\n– Insights derived from actual device submissions\, including EO\, irradiation.\nRegulatory Expectations & Best Practices\n– Interpretation of EU MDR 2017/745 and relevant ISO standards to support compliant sterilization documentation.\nStreamlining Submissions\n– Overview of updated biological safety checklists and guidance for more efficient MDR submissions.\n\n \nRegistration\n\nRegistration includes*: Admission to networking/cocktail reception & full event access\n\n  \n\n\n  \n  \n  \n 
URL:https://www.pdamidwest.org/event/sterilization-deficiencies/
LOCATION:TÜV SÜD Testing Lab\, 141 14th ST NW\, New Brighton\,\, MN\, 55112\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260422T183000
DTEND;TZID=America/New_York:20260422T193000
DTSTAMP:20260526T051204
CREATED:20260320T224336Z
LAST-MODIFIED:20260320T225114Z
UID:10000117-1776882600-1776886200@www.pdamidwest.org
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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20251216T103000
DTEND;TZID=America/Chicago:20251216T114500
DTSTAMP:20260526T051204
CREATED:20251203T213657Z
LAST-MODIFIED:20251203T213657Z
UID:10000112-1765881000-1765885500@www.pdamidwest.org
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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Indiana/Indianapolis:20251022T183000
DTEND;TZID=America/Indiana/Indianapolis:20251022T203000
DTSTAMP:20260526T051204
CREATED:20251001T190914Z
LAST-MODIFIED:20251021T154638Z
UID:10000111-1761157800-1761165000@www.pdamidwest.org
SUMMARY:PDA Purdue Student Chapter Event (in-person)
DESCRIPTION: \nPDA (Purdue) Midwest Student Chapter’s Meet the Professionals \n\n🌟 We’d love for you to join us!\nCurious about where your career can take you? Come spend an evening with us at the Parenteral Drug Association’s (PDA) Purdue Midwest Student Chapter’s Meet the Professionals event. \n📅 Date: Wednesday\, October 22\, 2025\n6:30pm – 8:30pm \n📍 Location:  Purdue University\nPurdue Jerry S. Rawls Hall (RAWL) – ROOM 1062\n100 S Grant St\,\nWest Lafayette\, IN 47907 \n\nWhat the night will offer\n\n\nYou’ll get the chance to hear from amazing professionals from Eli Lilly\, Sterilexcellence\, and PDA National. They’ll be sharing their own journeys! Focusing on how they got started\, the lessons they’ve learned\, and what helped them along the way! All are active PDA Members who have seen the benefits of being a member! \nAfterward\, we’ll have plenty of time for open Q&A\, conversation\, and networking. It’s the perfect space to ask your questions\, make new connections\, and see how PDA can support your goals and aspirations! \n💲 FREE for all students! \nJust Register below \n🍕 Did someone mention food?\nAnd of course – YES there will be food! \n🎩 Fancy vibes incoming—bring your best look!\nDress code: Casual to business casual \n🗣️ Curious minds welcome—let’s chat!\nCome with your questions\, your curiosity\, and an open mind! Follow us on Instagram to keep in touch with us: \nPDA Purdue Midwest Chapter Instagram Link \nQR Code: \n\n\n\n	Notice: JavaScript is required for this content.\n\n\n    \n\n\n        \n        \n                \n\n        \n\n        \n\nEvent Leaders\n\n📞 Got questions? Reach out to your PDA leaders!\n👩‍🏫 Renee Morley\nPDA Midwest Student Advisor\n📧 rmorley@contecinc.com\n📱 919-397-9189 \n🎓 Stefanie Bogs\nPDA Purdue Student Chapter President\n📧 sbogs@purdue.edu \n🎓 Kathryn Wilmot\nPDA Purdue Student Chapter Vice-President\n📧 wilmotk@purdue.edu
URL:https://www.pdamidwest.org/event/pda-purdue-student-chapter-event-in-person/
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20251008
DTEND;VALUE=DATE:20251010
DTSTAMP:20260526T051204
CREATED:20250730T165140Z
LAST-MODIFIED:20251006T202300Z
UID:10000110-1759881600-1760054399@www.pdamidwest.org
SUMMARY:2025 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 Flagship Event of 2025\, Sterility Assurance & Quality Risk Management Conference. \nsterility assurance & quality risk management conference\n\nMark your calendars for Wednesday\, October 8th\, and Thursday\, October 9th\, 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\, foster peer-to-peer discussions and showcasing exhibitors.  Plus\, don’t miss the chance to win raffle prizes after the afternoon break! \nagenda & venue\n\nSpeakers\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:
URL:https://www.pdamidwest.org/event/2025-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
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250507
DTEND;VALUE=DATE:20250509
DTSTAMP:20260526T051204
CREATED:20250207T195706Z
LAST-MODIFIED:20250502T210629Z
UID:10000108-1746576000-1746748799@www.pdamidwest.org
SUMMARY:17th Annual Microbial Contamination and Control Conference
DESCRIPTION:PDA Midwest Event\n\nMicrobial Contamination and Control\nPDA Midwest Chapter is pleased to announce that the chapter will partner with the Hilton Chicago Northbrook Hotel in Northbrook\, IL for one of our signature events\, the 17th Annual Microbial Contamination and Control Conference.  \nJoin us on Wednesday and Thursday\, May 7th and 8th for an agenda packed full of thought-provoking presentations addressing the opportunities and microbial challenges within the industry. Presentations will include topics such as Environmental Monitoring\, Contamination Control Strategies\, Root Cause Analysis and much more! \nRefreshment breaks will feature tabletop exhibits\, which will allow for peer-to-peer discussions and exhibitor showcase. In addition\, raffle prizes will be given out after the afternoon break on Thursday. \nAgenda & Venue\n\nAgenda Topics\n\n \n \n \nHilton Chicago-Northbrook\n2855 N. Milwaukee Ave.\nNorthbrook\, IL 60062\nRoom Rates reserved through PDA Midwest for $115/night (Rooms Available NOW)\n \n\n \nRegistration & sponsorship opportunity\n\nRegistration includes*: Admission to networking/cocktail reception & full event access\n\n*Bronze registration includes commercial slide at the beginning of the conference and recognition in emails \nThank you ALL sponsors\n\n \n  \n  \n 
URL:https://www.pdamidwest.org/event/17th-annual-microbial-contamination-and-control-conference/
LOCATION:Hilton Chicago-Northbrook\, 2855 North Milwaukee Ave\, Northbrook\, IL\, 60062\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20250121T173000
DTEND;TZID=America/New_York:20250121T193000
DTSTAMP:20260526T051204
CREATED:20250106T174953Z
LAST-MODIFIED:20250106T174953Z
UID:10000107-1737480600-1737487800@www.pdamidwest.org
SUMMARY:PDA Midwest STAQ Pharma Student Event
DESCRIPTION:exclusive students only event\n\nStep into the World of Pharmaceuticals – Join Us On January 21st!\n  \nThe Parenteral Drug Association’s (PDA) Midwest Chapter is excited to co-host with STAQ Pharma\, a 503B outsourcing compounding pharmacy. This event offers a behind-the-scenes look at STAQ’s manufacturing processes\, facility and the vital role compounding pharmacies play in patient safety and healthcare innovation. \nWhy You Should Attend: \nThis event offers a unique opportunity to gain real-world exposure to the pharmaceutical industry through a behind-the-scenes tour of an FDA registered 503B outsourcing compounding pharmacy. \nYou’ll benefit from career guidance as STAQ Pharma associates share their journeys and advice for your post-graduation plans\, while building connections through professional networking with industry leaders and peers. \nWith only 30 spots available\, this rare opportunity ensures a focused and personalized experiences bridging the gap between the classroom and your career goals. \n  \nAgenda & Venue\n\nJoin Us on January 21\, 2025\, from 5:30 – 7:30pm (Eastern Time Zone)\n\n\n\nActivity\nTime (EDT)\n\n\nWelcome and Introductions\n5:30 pm\n\n\nSpeakers\n5:30 pm ~ 6:30 pm\n\n\nTours and Networking\n6:30 pm ~ 7:30 pm\n\n\n\n\n\n\n\nLocation\nSTAQ Pharma\n255 Phillipi Rd.\nColumbus\, OH 43228\n \n \nAddmission\n\nFree Admission –  Registration is Needed\n\n  \nspecial thank you to Annual Sponsors!\n\n 
URL:https://www.pdamidwest.org/event/pda-midwest-staq-pharma-student-event/
LOCATION:STAQ Pharma\, 255 Phillipi Rd\, Columbis\, OH\, 43228\, United States
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20241204T130000
DTEND;TZID=America/New_York:20241204T143000
DTSTAMP:20260526T051204
CREATED:20241108T142014Z
LAST-MODIFIED:20241108T142014Z
UID:10000106-1733317200-1733322600@www.pdamidwest.org
SUMMARY:Application of Essential Contamination Control Principles in Compounding Environments
DESCRIPTION:Application of Essential Contamination Control Principles in Compounding Environments\n\nJoin PDA Midwest Chapter for an insightful presentation featuring Michael T. Myers\, Clinical Support Manager\, Contec\, Inc.\, and Melanie Dorey\, R.Ph.T\, Owner/Consultant\, Critical Compounding Resources (Canada and US)\, as they explore the four essential contamination control principles through real-world case studies. This session will cover critical topics\, including hand hygiene and garbing\, material handling in compounding environments and then into ISO Class 5 environments\, operator conduct within the compounding environments\, and aseptic techniques within ISO Class 5 settings. To enhance your learning experience\, we will dedicate 30 minutes at the end for an interactive Q&A session. We encourage you to come prepared with questions related to effective contamination control strategies!  \nPresented by: Michael Myers\, Contec\, Inc\, and Melanie Dorey\, R.Ph.T\,  Critical Compounding Resources \n  \n\nPresentation Date and Time\n\n\nWednesday\, December 4\, 2024 @ 1:00pm (Eastern time zone)\n\n  \nPresenters – Bio\n\nMichael T Myers\, Clinical Support Manager\, Contec\, Inc.:\nMichael Myers brings a wealth of expertise and a longstanding dedication to Contec\, Inc.\, having joined the company in 1998. Throughout his tenure\, he has held various key positions\, including product development\, sales management\, and technical support. For over a decade\, Michael has demonstrated an unwavering commitment to the success of Sterile Compounding Pharmacies\, focusing on their specific needs and challenges. \nAs the Clinical Support Manager for Contec’s Healthcare division\, Michael plays a pivotal role in developing educational resources and conducting in-service training for pharmacy technicians. His mission is to equip them with the best practices for maintaining clean and disinfected environments in 503A compliant compounding pharmacies\, ensuring compliance with the stringent guidelines outlined in USP Chapters <797> and <800>. \nIn recognition of his outstanding contributions\, Michael was honored with the prestigious John Martin Outstanding New Member Award by the Institute of Environmental Sciences and Technology (IEST) in 2022. He holds a Bachelor of Science degree in Communications from Appalachian State University\, which further strengthens his ability to effectively communicate and provide valuable support to pharmacy professionals. \nWith his extensive experience\, industry knowledge\, and commitment to excellence\, Michael continues to drive innovation and foster the success of Sterile Compounding Pharmacies under the Contec Healthcare division. \nMelanie Dorey\, R.Ph.T\, Owner/Consultant\, Critical Compounding Resources:\n\nMelanie Dorey is a registered pharmacy technician and has worked in the compounding industry since 2006. She graduated from a 2-year Pharmacy Technician program in 2006 and at the Children’s Hospital of Eastern Ontario (CHEO) where she acquired a passion for sterile and nonsterile compounding. While attending the Sterile Compounding Boot Camp in Denver\, Colorado in 2007\, Melanie met several key industry experts who ignited her passion for sterile and nonsterile compounding. In 2014\, she joined the team at CriticalPoint and Kastango Consulting Group where she continued to hone her skills while developing eLearning\, standard operating procedures\, as well as in person and virtual lectures. She also traveled to client locations to perform competency assessment and customized training. Melanie has served on a variety of committees with NAPRA and the Ontario College of Pharmacy. Melanie is the owner of Critical Compounding Resources which offers services to compounding operations across North America. \n  \nRegistration\n\nThanks to our sponsor\, webinar registration is FREE\n\n  \n\nRegister Now \n 
URL:https://www.pdamidwest.org/event/application-of-essential-contamination-control-principles-in-compounding-environments/
LOCATION:Virtual Presentation
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20241114T110000
DTEND;TZID=America/Chicago:20241114T123000
DTSTAMP:20260526T051204
CREATED:20241029T203317Z
LAST-MODIFIED:20241031T004204Z
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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20241023T173000
DTEND;TZID=America/New_York:20241023T193000
DTSTAMP:20260526T051204
CREATED:20240915T160438Z
LAST-MODIFIED:20240915T160504Z
UID:10000104-1729704600-1729711800@www.pdamidwest.org
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
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20241015
DTEND;VALUE=DATE:20241017
DTSTAMP:20260526T051204
CREATED:20240802T160838Z
LAST-MODIFIED:20241014T013250Z
UID:10000103-1728950400-1729123199@www.pdamidwest.org
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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240918T180000
DTEND;TZID=America/Chicago:20240918T203000
DTSTAMP:20260526T051204
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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20240808T110000
DTEND;TZID=America/Chicago:20240808T123000
DTSTAMP:20260526T051204
CREATED:20240621T170838Z
LAST-MODIFIED:20240802T161023Z
UID:10000101-1723114800-1723120200@www.pdamidwest.org
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
END:VEVENT
END:VCALENDAR