show episodes
 
I love games!!! Specifically I love the games we play in youth ministry. This podcast will be the place where you can come to find fun games for your own ministry as well as some commentary on how to make games more fun.
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RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing. RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ t ...
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For anyone interested in the nuts and bolts of real-life collaboration, especially collaboration among creative, intelligent, free-thinking individuals who are geographically dispersed. These interviews go well beyond the obvious, as metaphor master Judy Rees explores the hidden thinking that inspires collaboration that works.
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Artwork
 
Your gateway to literary excellence. Unveiling captivating tales and timeless classics. Embrace the art of reading with our curated gems. 📚✨ #BookDiscoveries #Books #eBooks #Audiobooks #PDF #Kindle #Mobi #ePub Powered by Firstory Hosting
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show series
 
𝗡𝗘𝗪𝗦 → FDA releases final rule on Laboratory-Developed Tests (LDTs) 🚨 RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including: ✅ The 4-year phase-in timeline for compliance ✅ Expanded enforcement discretion for certain LDTs ✅ Grandfathering clause for currently marketed LDTs Watch now …
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🔬 Hot on the heels of Jordi Labs' groundbreaking new publication support for simulated use testing of blood-contacting medical…
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In this special bonus clip from our Excellence Spotlight series, Sr. Director of Data Operations (Clinical Trials) Noel Keegan takes a deep dive into clinical data management. From the transition to electronic systems to the exciting potential of AI, Noel reflects on the evolution he's witnessed over his 16+ year career. He breaks down the key aspe…
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While we believe you will find Nancy's story and advice inspiring without visuals, we encourage you to watch the video version containing a brief presentation on the RQM+ website here. In this heartfelt and insightful video presentation, now available on our blog, Nancy Morrison, RAC shares her journey and the lessons she's learned along the way. N…
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This show was recorded 28 March 2024. We encourage you to download the presentation given in the first portion of this session by ⁠completing the form on this page⁠. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠⁠Knowledge Center⁠⁠ or ⁠⁠Events⁠⁠ pages a…
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Our Excellence Spotlight interview series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. These employees are committed to technical excellence and make significant positive contributions to our clients' success. In our newest interview, we're thrilled to showcase Vice President of Strategic Regulatory Affairs, …
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RQM+ Vice President of Global Regulatory Affairs (and former BSI), Jaishankar Kutty, Ph.D., discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip. In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilit…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 With a fascinating career spanning drug development with GSK to addressing ESPN's water issues, RQM+ / Jordi Labs Senior Stu…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. Our newest Excellence Spotlight interview is with Noel Keegan, a central figure in RQM+ clinical trial services. Noel is Sr. D…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🔬 Kaitlin Lerner is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most bril…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. Yesterday, we published a clip of RQM+ Senior Consultant Anastassia Young, MS discussing our recent conversation with the FDA …
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Are you navigating adverse event (AE) reporting in post-market clinical follow-up (PMCF) studies? In a recent discussion with the FDA, we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden. This collaboration between RQM+ and the FDA paves the way for a more efficient …
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This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠Knowledge Center⁠ or ⁠Events⁠ pages at RQMplus.com. Th…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🌌 Meet the supremely talented Song Seto, PhD, RAC in our latest Excellence Spotlight interview. Song is a Principal in our RA/…
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Summary This discussion provides a high-level overview of the current state of artificial intelligence (AI) in in vitro diagnostics (IVDs). The conversation between Director of IVD Intelligence and Innovation, Margot Borgel, and Principal Regulatory Scientist, Bethany Chung, Ph.D., RAC, covers several aspects of AI in IVDs, including its use in dia…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🔬 Meet RQM+ Director of Biological Evaluation Consulting, Taryn Meade, in our latest Excellence Spotlight interview! Jaishanka…
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📢 Hear Jaishankar Kutty, Ph.D.'s four-minute summary on MDCG 2023-7 and how you can benefit from attending next week's RQM+ Live! panel discussion: New Clinical Evidence Pathways for Legacy and New Devices. 🎟️ RSVP for the 22 February event here. Why are we talking about this? To address and clarify potential misinterpretations of Article 61, Items…
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🏥 In connection with the FDA’s recent approval of Edwards Lifesciences’ transcatheter tricuspid valve replacement device, here is some commentary from RQM+ Vice President of Intelligence & Innovation, Jaishankar Kutty, Ph.D., about the importance of the benefit-risk story within the target patient population under the aegis of the state of the art …
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. From bioengineering student at the University of Pittsburgh to PMCF study leader, meet Garrett Jeffries, PhD in our newest Exc…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 📜 Elizabeth Starling went from law school aspirations to becoming a force in regulatory affairs and clinical research as a Sen…
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💬 New MedTech Voices Episode: Sally Sennitt and Jaishankar Kutty, Ph.D. dissect the expert panel's review of a groundbreaking extravascular implantable cardiac defibrillator (ICD) and offer insights into regulatory challenges and cardiac care innovation. Takeaways: 👇 Expert Review Insights for a Novel Extravascular ICD: Get an insider's perspective…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🌟 A seasoned expert in global regulatory affairs and project management, Senior Manager Laurie Pettit, PMP shares her journey …
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MedTech Moments are a curated selection of the most impactful snippets from our expert panel discussions. This clip was taken from RQM+ Live! #72 – EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance. What makes a good EU MDR program from a maintenance perspective? We answered this question in RQM+ Live! #72, …
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. Meet Nicholas Wilson, Ph.D. – Principal, Clinical and Post-Market Practice – in our new Excellence Spotlight interview. What m…
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Have you seen the proposed amendments to MDR and IVDR published this week? Margot Borgel, Ph.D. and Jaishankar Kutty, Ph.D. sat down to discuss the details of this proposal, the potential impacts to manufacturers, and some questions and concerns surrounding this proposal. All current transition timelines have been extended by 2.5 years with new dea…
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This show was recorded 18 January 2024. Download the slides from this presentation (including bonus slides not presented) by submitting the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com. …
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 2️⃣ things we're excited about today... 1. Our new Excellence Spotlight interview featuring RQM+ Senior Principal and former F…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🎆 Happy new year! We're bringing the most positive energy we can to start 2024 with a heartwarming and uplifting RQM+ Excellen…
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🎄 This week's Excellence Spotlight shines on a standout member of our clinical and post-market team, Senior Consultant / Capab…
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After a lull which has now picked up with FDA approvals, what's next for renal denervation? RQM+ VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. shares the knowns and unknowns in a new video clip. 📝 Quick summary Renal denervation is a technology that aims to control blood pressure by disrupting renal nerve activity through a minimally in…
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(Discover the book Now) The Travelling Cat Chronicles By Hiro Arikawa Full Pages PDF Audio-books and eBook. =========== Immerse yourself in a tale of love, loss, and triumph. Your next great read awaits! Don't miss out � grab your copy today and lose yourself in a story that will stay with you long after the last page.. =========== ((CLICK / COPY T…
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(Get the book Now) It's a Wonderful Woof (A Chet & Bernie Mystery, #12) By Spencer Quinn Full Pages PDF Audio-books and eBook. =========== Embark on a journey of mystery and intrigue! Dive into the latest book and discover a world where every page holds a new adventure. Are you ready to escape reality?. =========== ((CLICK / COPY THE LINK to read t…
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(Discover the book Now) A Dog's Perfect Christmas By W. Bruce Cameron Full Pages PDF Audio-books and eBook. =========== Discover a world where dreams come alive and possibilities are endless. My book is more than just words on paper � it's a journey. Take the first step. Order now and let the magic begin!. =========== ((CLICK / COPY THE LINK to rea…
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(Discover the book Now) Purrfect Murder (The Mysteries of Max, #1) By Nic Saint Full Pages PDF Audio-books and eBook. =========== Discover a world where dreams come alive and possibilities are endless. My book is more than just words on paper � it's a journey. Take the first step. Order now and let the magic begin!. =========== ((CLICK / COPY THE L…
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(Get the book Now) Remarkably Bright Creatures By Shelby Van Pelt Full Pages PDF Audio-books and eBook. =========== Calling all book lovers! My latest creation is here, waiting to transport you to a world of imagination. Dive into a story that will captivate your heart and mind. Ready to start the adventure?. =========== ((CLICK / COPY THE LINK to …
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(Read the book Now) Watership Down By Richard Adams Full Pages PDF Audio-books and eBook. =========== Immerse yourself in a tale of love, loss, and triumph. Your next great read awaits! Don't miss out � grab your copy today and lose yourself in a story that will stay with you long after the last page.. =========== ((CLICK / COPY THE LINK to read th…
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(Get the book Now) Rescue Mission (Rocky Mountain K-9 Unit Book 8) By Lynette Eason Full Pages PDF Audio-books and eBook. =========== Immerse yourself in a tale of love, loss, and triumph. Your next great read awaits! Don't miss out � grab your copy today and lose yourself in a story that will stay with you long after the last page.. =========== ((…
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(Get the book Now) Horse By Geraldine Brooks Full Pages PDF Audio-books and eBook. =========== Embark on a journey of mystery and intrigue! Dive into the latest book and discover a world where every page holds a new adventure. Are you ready to escape reality?. =========== ((CLICK / COPY THE LINK to read this book)): https://saskiyafirsbooks.blogspo…
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(Read the book Now) Horse By Geraldine Brooks Full Pages PDF Audio-books and eBook. =========== Calling all book lovers! My latest creation is here, waiting to transport you to a world of imagination. Dive into a story that will captivate your heart and mind. Ready to start the adventure?. =========== ((CLICK / COPY THE LINK to read this book)): ht…
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(Discover the book Now) Earth Angel By Madeline Cash Full Pages PDF Audio-books and eBook. =========== Discover a world where dreams come alive and possibilities are endless. My book is more than just words on paper � it's a journey. Take the first step. Order now and let the magic begin!. =========== ((CLICK / COPY THE LINK to read this book)): ht…
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(Read the book Now) I Fear My Pain Interests You By Stephanie LaCava Full Pages PDF Audio-books and eBook. =========== Embark on a journey of mystery and intrigue! Dive into the latest book and discover a world where every page holds a new adventure. Are you ready to escape reality?. =========== ((CLICK / COPY THE LINK to read this book)): https://…
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(Discover the book Now) Fool By Christopher Moore Full Pages PDF Audio-books and eBook. =========== Calling all book lovers! My latest creation is here, waiting to transport you to a world of imagination. Dive into a story that will captivate your heart and mind. Ready to start the adventure?. =========== ((CLICK / COPY THE LINK to read this book))…
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(Get the book Now) Jonathan Abernathy You Are Kind By Molly McGhee Full Pages PDF Audio-books and eBook. =========== Immerse yourself in a tale of love, loss, and triumph. Your next great read awaits! Don't miss out � grab your copy today and lose yourself in a story that will stay with you long after the last page.. =========== ((CLICK / COPY THE …
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(Discover the book Now) The Guest Lecture By Martin Riker Full Pages PDF Audio-books and eBook. =========== Unlock the secrets within the pages of my newest release! Join the ranks of readers who have experienced the thrill. Grab your copy now and get ready for a rollercoaster of emotions!. =========== ((CLICK / COPY THE LINK to read this book)): h…
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(Get the book Now) Faking It with the Grumpy Billionaire Daddy (Star Island Lovers) By Haley Storm Full Pages PDF Audio-books and eBook. =========== Unlock the secrets within the pages of my newest release! Join the ranks of readers who have experienced the thrill. Grab your copy now and get ready for a rollercoaster of emotions!. =========== ((CLI…
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(Get the book Now) Life Ceremony By Sayaka Murata Full Pages PDF Audio-books and eBook. =========== Discover a world where dreams come alive and possibilities are endless. My book is more than just words on paper � it's a journey. Take the first step. Order now and let the magic begin!. =========== ((CLICK / COPY THE LINK to read this book)): https…
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(Get the book Now) The Complete Stories of Leonora Carrington By Leonora Carrington Full Pages PDF Audio-books and eBook. =========== Embark on a journey of mystery and intrigue! Dive into the latest book and discover a world where every page holds a new adventure. Are you ready to escape reality?. =========== ((CLICK / COPY THE LINK to read this b…
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(Read the book Now) Comemadre By Roque Larraquy Full Pages PDF Audio-books and eBook. =========== Unlock the secrets within the pages of my newest release! Join the ranks of readers who have experienced the thrill. Grab your copy now and get ready for a rollercoaster of emotions!. =========== ((CLICK / COPY THE LINK to read this book)): https://rea…
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(Discover the book Now) People from My Neighborhood By Hiromi Kawakami Full Pages PDF Audio-books and eBook. =========== Calling all book lovers! My latest creation is here, waiting to transport you to a world of imagination. Dive into a story that will captivate your heart and mind. Ready to start the adventure?. =========== ((CLICK / COPY THE LIN…
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(Discover the book Now) Grumpy Bad Boy Santa By Aria McDow Full Pages PDF Audio-books and eBook. =========== Unlock the secrets within the pages of my newest release! Join the ranks of readers who have experienced the thrill. Grab your copy now and get ready for a rollercoaster of emotions!. =========== ((CLICK / COPY THE LINK to read this book)): …
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