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UID:11794-1773855000-1773861300@www.mfests.org
SUMMARY:ASQ: Biomedical Consortium - Situational Leadership
DESCRIPTION:Situational Leadership – \nInfluence people to build solutions\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nYou didn’t get into quality to be the bottleneck. \nYou’re here to build excellence and ensure quality. But if your days are filled with friction\, constantly having to enforce rules with resistant colleagues and frustrated teams\, it’s exhausting. Being seen as the primary rule enforcer can make you feel like a bottleneck\, not a strategic partner. \nIt’s time for a new approach. \nIn this 90-minute virtual masterclass\, you will learn a proven leadership framework to diagnose why people resist and exactly how to adapt your approach to get buy-in\, reduce conflict\, and champion quality effectively. \n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nClick Here for more info or to register!
URL:https://www.mfests.org/event/asq-biomedical-consortium-virtual-session/
LOCATION:Webinar
CATEGORIES:ASQ
ORGANIZER;CN="ASQ-MN%20Section":MAILTO:info@mnasq.org
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BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250813T180000
DTEND;TZID=America/Chicago:20250813T200000
DTSTAMP:20260412T071322
CREATED:20250702T024940Z
LAST-MODIFIED:20250702T024940Z
UID:11667-1755108000-1755115200@www.mfests.org
SUMMARY:ASQ: What does CMMI\, the FDA and Your Organization's Maturity Have in Common?
DESCRIPTION:What is maturity\, when applied to a company? Simply\, it is a quantifiable measure of how consistently and efficiently a company operates\, and how well it can identify and meet its key process metrics. \nIn 2011\, the FDA launched its Case for Quality.  They saw that just being compliant with the Quality System Regulations (QSR) did not make companies produce better products.   The FDA worked with Medical Alley to create a new public-private partnership so the FDA could work directly with industry.  The FDA’s Voluntary Improvement Program (VIP)\, launched in 2018\, is a way to assess your organization’s maturity to industry best practices while getting some preferential treatment by the FDA.  The VIP program leverages the Capability Maturity Model for Integration (CMMI) model and lets you tailor the assessments to where you need help the most. \nJoin in the discussion with Mark as he reviews: \n\nThe history of MDIC\nThe history of CMMI\nOrganizational maturity concepts\nThe FDA VIP program and benefits\nEffects of the new QMSR\nCase studies\n\nWho should attend?  Individuals who want to promote continuous quality improvement beyond regulatory compliance. \nVenue: Online. A Zoom link will be sent to all registrants closer to the event date. \nDate: Tuesday\, August 13\, 2025 \nTime:  6:00 pm to 8:00 pm CST \nCost: \n\nASQ Members $15\nNon-Members $25\nStudents\, $10 when registering with your valid\, current school email.\nGroups of 5 or more will receive the Member rate.\n\nCertificates of Completion: Issued via email\, after event completion\, for .2 ASQ RUs or .2 CEUs \nPlease contact Karen Peifer\, Committee Chair\, at asqmnbmc@gmail.com if you have any questions. \nYour Speaker \nMark Rutkiewicz\, Consiliso\, LLC \nFor over 35 years\, Mark Rutkiewicz has led Quality organizations and has managed company business processes in six medical device companies.  He has designed Quality Management Systems for active and non-active implantables\, disposables\, combo devices\, software and capital systems.  Mark built and rebuilt online integrated corporate-wide quality/business systems.  He has a Bachelor of Electrical Engineering from the University of Minnesota and a Masters of Applied Liberal Studies from Hamline University.  Mark retired in 2024\, but started his own consulting company Consiliso LLC.  Mark is the author of two books on Consiliso\, which define how to create reconfigurable organizations and implement integrated business processes.  He led efforts for the MDIC’s Case for Quality (CfQ) Voluntary Improvement Program (VIP) and is involved in the MDIC Safe Space program. \nSponsor Information \nThe MN ASQ Biomedical Consortium (BMC) is a group of quality professionals promoting and advancing quality tools\, principles\, and practices through educational events.  We focus on the medical device industry but promote events for other regulated environments. \n\nFollow us on LinkedIn to stay informed of upcoming events:  https://www.linkedin.com/showcase/90642322/\n\nTo become a member of the MN ASQ Biomedical Consortium\, please contact Karen Peifer\, Committee Chair or Sahi Datla\, Committee Co-Chair\, at asqmnbmc@gmail.com. \nThe American Society for Quality (ASQ)\, is a knowledge-based global community of quality professionals\, with nearly 80\,000 members dedicated to promoting and advancing quality tools\, principles\, and practices in their workplaces and communities.  As your career partner\, ASQ membership benefits are designed to help meet your growing needs as a quality professional.  Membership provides exclusive access to quality knowledge\, solutions\, and resources to solve challenges\, and skill development to advance your career. ASQ is committed to providing enhanced expertise\, professional networks\, tools\, and solutions to help our members advance their products\, services\, and industries. \nASQ:  https://www.asq.org/ \nMore information
URL:https://www.mfests.org/event/asq-what-does-cmmi-the-fda-and-your-organizations-maturity-have-in-common/
LOCATION:Webinar
CATEGORIES:ASQ
ORGANIZER;CN="ASQ-MN%20Section":MAILTO:info@mnasq.org
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BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250812T170000
DTEND;TZID=America/Chicago:20250812T210000
DTSTAMP:20260412T071322
CREATED:20250702T024708Z
LAST-MODIFIED:20250702T024708Z
UID:11665-1755018000-1755032400@www.mfests.org
SUMMARY:ASQ: Program Meeting August 2025 - Networking Event
DESCRIPTION:Come join us….. \nThere is plenty of social space\, and we will have lots to do\, like Bowling\, Bocce Ball\, Corn Hole\, Bucket Toss\, and Giant Jenga. There will also be a buffet with two drink tickets per person. \nLocation:  1691 Park Place Blvd.\, Minneapolis\, MN 55416 \nCost:  $20 per person. A plus-one is welcome!  Please register your guest as well. We have 50 spots available.   Your guest does not have to be an ASQ member to join us. \nVenue Information: https://punchbowlsocial.com/location/minneapolis/ \n\nMore information
URL:https://www.mfests.org/event/asq-program-meeting-august-2025-networking-event/
LOCATION:Punch Bowl Social Minnepolis\, 1691 Park Place Boulevard\, St. Louis Park\, Minnesota\, 55416
CATEGORIES:ASQ
ORGANIZER;CN="ASQ-MN%20Section":MAILTO:info@mnasq.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Chicago:20250708T183000
DTEND;TZID=America/Chicago:20250708T200000
DTSTAMP:20260412T071322
CREATED:20250702T024448Z
LAST-MODIFIED:20250702T024448Z
UID:11663-1751999400-1752004800@www.mfests.org
SUMMARY:ASQ: Program Meeting July 2025 - ISO 9001 Updates
DESCRIPTION:July 2025 Program Meeting – “ISO 9000 & 9001: Changes coming in 2025\, 2026 & 2027 – Perspectives from an ISO Working Group Member” by Mark Swanson\n\n\n\n\n\n\n\nWhen: Tuesday\, July 8\, 2025 \nWhere: Virtual \nRecertification units available: \n0.1 RU Meeting (Business/Networking)\n0.1 RU Workshop (1 hour) \nAgenda: \n6:30 P.M.  Welcome\, Announcements\n7:00 P.M.  Presentation: Mark Swanson\, “ISO 9000 & 9001: Changes coming in 2025\, 2026 & 2027 – Perspectives from an ISO Working Group Member”\n7:55 P.M.  Closing Notes \nAbout the Presentation: \nTitle: ISO 9000 & 9001: Changes coming in 2025\, 2026 & 2027 – Perspectives from an ISO Working Group Member \nAttend this presentation to learn more about: \n\nRestored appreciation for the content in ISO 9000 – we will outline how this sets the foundation for your quality management requirements and the expectations for the results that implementing a QMS should have\nUnderstanding working group member perspective on ‘changes’ to ISO 9001\nThoughts on how to prepare for the publication of the revisions to ISO 9001\nHow you can provide input to the revisions of ISO 9000/9001 (and 9002)\n\nMark will answer your questions on the content of these key standards \nAbout Our Speaker: \nMark Swanson (MBA\, ASQ CMQ/OE\, CQE\, CMDA) is one of the Founding Partners of Quality and Regulatory Expert Partners\, LLC; a partnership focused on helping small to mid-sized companies have the same regulatory and quality management systems knowledge as large companies. Mark has more than 25 years of experience in the medical device industry/quality management\, including numerous quality and regulatory roles. He is a senior member of ASQ\, RAPS member and a corporate AAMI member (serving on several AAMI standard development committees). Mark currently serves as the exam chair for the Certified Medical Device Auditor (CMDA) certification through ASQE. \nMark has spent the last several years as an active member of ISO Technical Committee 210 (ISO TC210)\, Working Group 1 (WG1) working on ISO 13485 that was published in March 2016. He is the project leader to update the Practical Guide (handbook) on ISO 13485 (ISO TS 23485) and in the AAMI group responsible for TIR 102\, the comparison of ISO 13485 to the US FDA Quality System Regulation and contributor to the Advisory group for the final rule (new QMSR). He also participates with ISO TC176 on ISO 9000/9001:2015 and is currently part of both working groups on the revisions to be published in 2025/2026 and the secretary of the group updating ISO 9002. To add to this\, Mark also participates in the US TAG for risk management (ISO 14971) and liaison from ISO TC210 to ISO TC262 for risk management. In this work he leads the discussions regarding the impact of changes in the ISO management system standards (MSSs) and how to effectively integrate these various international standards and other regulations into a single management system. \nRegister now using the link below! \n\n\n\n\nMore information
URL:https://www.mfests.org/event/asq-program-meeting-july-2025-iso-9001-updates/
LOCATION:Webinar
CATEGORIES:ASQ
ORGANIZER;CN="ASQ-MN%20Section":MAILTO:info@mnasq.org
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