This panel was recorded 12 December 2024. Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com. Thank you for tuning in. As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical. Join our expert panel for a practical, strategic discussion that cuts through the complexity of cybersecurity guidance and delivers actionable...
Dec 19, 2024•1 hr 3 min•Transcript available on Metacast This panel was recorded 21 November 2024. Please join us live for future shows for the chance to participate in the chat and ask your own questions! You can sign up for these events and see more free thought leadership content in the Knowledge Center at RQMplus.com. Thank you for tuning in. As significant changes to ISO 10993-1 loom on the horizon, manufacturers across MedTech are seeking clarity on what's coming and how to prepare. Join our expert panel for an essential discussion on these upco...
Dec 05, 2024•58 min•Transcript available on Metacast 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. interview: Chris A. Parr, PMP With over 20 years in regulatory and quality compliance, Chris exemplifies RQM+'s deep expertise and commitment to our clients. From leading complex FDA 510(k) submissions to building robust EU MDR frameworks post-Brexit, Chriss strategic insight...
Nov 14, 2024•13 min•Transcript available on Metacast 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. An 18-yr old McDonald's manager at Purdue University's campus restaurant just so happened to find her making consistently perfect burgers. Today, Carrie (Habegger) Schneider is a Principal Consultant at RQM+, with three (!) degrees earned while raising three (!) kids Her expe...
Nov 07, 2024•15 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* ? Did you know 60-80% of IVD 510(k)s require clinical data? In this must-watch video, Director of IVD Global Regulatory Affairs Margot Borgel, Ph.D. is joined by Nancy Morrison, RAC (with 30+ years of regulatory experience) and th...
Nov 04, 2024•10 min•Transcript available on Metacast 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 interview is an especially fun one! From National Geographic subscriptions to successfully navigating FDA submissions, meet Senior Consultant Holly Cotter, RAC, CBA . Driven by a palpable curiosity since childhood, she's transformed her love for learning into a thr...
Oct 28, 2024•15 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In the final installment of this three-part series, Jaishankar Kutty, Ph.D. concludes the discussion with former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scient...
Oct 22, 2024•10 min•Transcript available on Metacast This presentation and panel was recorded 4 October 2024. We encourage you to download the slides presented during this session by completing the form on this page . Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to occasional traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com. Thank you for tuning in. Join us ...
Oct 17, 2024•1 hr 2 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In part two of a three-part series, Jaishankar Kutty, Ph.D. continues the discussion with former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) on...
Oct 15, 2024•9 min•Transcript available on Metacast 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. After highlighting many members of our Jordi Labs, an RQM+ Company team in the past two months, we're returning to RA/QA this week. Today we're delighted to share Jaishankar Kutty, Ph.D. 's interview with Principal Consultant, Christine Anderson , RAC. Learn how Christine's j...
Oct 14, 2024•11 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In part one of a three part series, Jaishankar Kutty, Ph.D. hosts former FDA lead reviewer Ryan Randall and ex-BSI clinical compliance head Amie Smirthwaite (current RQM+ Senior VP of Scientific Affairs) to unpack the intricacies ...
Oct 10, 2024•22 min•Transcript available on Metacast 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 run of interviews with our Jordi Labs, an RQM+ Company team members continues with Christine Santagate, RAC chatting with Senior Chemist II and supervisor of our gas and liquid chromatography teams, Michael Louis, Ph. D. Listen in to hear how Mike became a , known for his...
Oct 08, 2024•6 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* Watch our newest video to learn best practices for . Manager of Safety Management Melanie Miller reveals: AE definitions for medical devices vs. drugs Global reporting requirements and timelines Minimum data set for reportable AEs...
Oct 02, 2024•13 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In our latest clinical trials video, Manager of Safety Management Melanie Miller joins Jaishankar Kutty, Ph.D. to discuss the . Melanie covers: Key components of effective safety management Pre-enrollment planning and study protoc...
Sep 26, 2024•11 min•Transcript available on Metacast This presentation and panel was recorded 12 September 2024. We encourage you to download the slides presented during this session by completing the form on this page . Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to occasional traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com. Thank you for tuning in. The r...
Sep 26, 2024•1 hr 8 min•Transcript available on Metacast 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 interview series continues as Christine Santagate, RAC chats with Dr. Anthony Grice, a leading chemist at Jordi Labs for over a decade! Discover how "Ant" became our go-to , solving complex problems with creativity. Ant shares: His journey from the UK to becomin...
Sep 25, 2024•8 min•Transcript available on Metacast 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 interview series continues this week, as Christine Santagate, RAC is joined by Lab Coordinator Craig Young of the Jordi Labs team. Discover how Craig's diverse background in chemistry and project management led him to become an . Craig shares: His journey from WPI to ...
Sep 16, 2024•11 min•Transcript available on Metacast 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 interview series continues this week, as Christine Santagate, RAC is joined by Chemist II Michael Morales of the Jordi Labs team. Discover how Michael's passion for chemistry led him to becoming a . Michael shares: His journey through academia and into industry The im...
Sep 12, 2024•8 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* In our third and final clinical trials video focused on data management, Senior Director of Data Operations Noel Keegan returns to speak with Jaishankar Kutty, Ph.D. about the . Noel covers: The importance of partnership between C...
Sep 11, 2024•15 min•Transcript available on Metacast 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 short interview series continues this week, as Christine Santagate, RAC is joined by another member of the Jordi Labs team, Tommy Kumlin . See how Tommy's background in chemistry and chemical engineering led him to become a jack-of-all-trades in analytical techniques....
Sep 04, 2024•7 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* The data management party continues! Part 2 of our clinical trial data management series is here! Jaishankar Kutty, Ph.D. welcomes back Senior Director of Data Operations, Noel Keegan, to dive into the of clinical trial data manag...
Sep 03, 2024•14 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* It's a data management party you in? Our team had a ton of fun recording the newest video in our clinical trial video series and it's now available. Jaishankar Kutty, Ph.D. speaks with Senior Director of Data Operations, N...
Aug 28, 2024•14 min•Transcript available on Metacast 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 series of interviews with RQM+ employees returns today as Christine Santagate, RAC is joined by enthusiastic Jordi Labs Technical Program Lead Joshua Nott . Hear how Josh's journey from biochemistry to analytical chemistry led him to excel in customer service and tech...
Aug 27, 2024•9 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials. In these two videos (this is video 2) specific to site selection and monitor...
Aug 16, 2024•9 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* Explore in vitro diagnostic (IVD) clinical trial site selection and monitoring with our latest videos in our educational video series on clinical trials. In these two videos (this is video 1) specific to site selection and monitor...
Aug 15, 2024•10 min•Transcript available on Metacast This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by completing the form on this page . Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center at RQMplus.com. Thank you for tuning in. RQM+ welcomes ...
Aug 14, 2024•1 hr 6 min•Transcript available on Metacast Our ongoing educational video series on covers three areas: Strategy Execution Regulatory Optimize your IVD clinical trials and watch our newest video in the series: . Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D., is joined by Senior Director of Clinical Operations, Brandy Chittester, and Director of Business Development, Lauren Birch. : Outsourcing decisions and resource allocation Critical pre-clinical testing considerations Choosing the right clinical lab partner Efficient ...
Aug 06, 2024•10 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* We recently covered Site Selection In Clinical Trials and we're coming right back to share a new video on . For , Jaishankar Kutty, Ph.D. is rejoined by Senior Director of Clinical Operations, Brandy Chittester, and also joine...
Aug 02, 2024•13 min•Transcript available on Metacast *This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* Our newest video: . Senior Director of Clinical Operations Brandy Chittester and Study Start-Up Associate Elicia Dellinger join Jaishankar Kutty, Ph.D. to explore the process. : Key factors influencing site selection The step-by-s...
Jul 31, 2024•13 min•Transcript available on Metacast This was recorded 18 July 2024. We encourage you to download the presentation slides by completing the form on this page . Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the Knowledge Center or Events pages at RQMplus.com. Thank you for tuning in. The recently finalized EPA rule on ethyl...
Jul 18, 2024•48 min•Transcript available on Metacast 
