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DTSTART;TZID=America/Chicago:20260428T170000
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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
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DTSTART;TZID=America/Chicago:20240808T110000
DTEND;TZID=America/Chicago:20240808T123000
DTSTAMP:20260525T033008
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
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