BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//PDA Midwest - ECPv6.5.1.5//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-ORIGINAL-URL:https://www.pdamidwest.org
X-WR-CALDESC:Events for PDA Midwest
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/Chicago
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20260308T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20261101T070000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20260428T170000
DTEND;TZID=America/Chicago:20260428T203000
DTSTAMP:20260429T100947
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
END:VCALENDAR