Let's Combinate: Drugs + Devices

162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them) drops at 5AM CST tomorrow morning on Youtube, Spotify and Apple Podcasts!

ISO 14971 vs ICH Q9 Explained: Risk Management for Devices and Drugs is live! https://lnkd.in/gpEF_3ZW

160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED is now live!

159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin just dropped on Youtube, Apple and Spotify! https://lnkd.in/gMEbjtE3

Episode 158 drops at Oct 16 at 5AM CT + Name Change! Three years ago, I launched this podcast with a personal mission: to deepen my understanding of industry and create a space where I could ask the questions I had. What began as a journey to build my own mastery has grown into an incredible learning experience that I’ve been fortunate to share with all of you. For 157 consecutive weeks at 5AM on Wednesdays, I’ve released episodes that helped me grow while shining a light on the experts, innovators, and leaders in our field. Whether it’s navigating complex regulations, tackling manufacturing challenges, or exploring cutting-edge technologies, each episode has brought me closer to understanding this world of drug/device combinations—and I hope it’s been just as valuable for you, my listeners. I want to take a moment to thank YOU—the listeners, the Combi-Nation. Your engagement, feedback, and support have been the driving force behind this podcast. Whether you’ve been here since the very beginning or joined more recently, you’ve played a huge part in shaping the show into what it is today. After reflecting on this journey, and listening to your feedback, I’m excited to announce a change...... As I continue to grow alongside the industry, it’s time for the podcast to evolve too. I’ve decided to change the name of the show from The Combinate Podcast to Let’s Combinate, and as part of that evolution, I’m thrilled to say that the show is now on YouTube as well! This new name speaks to the collaborative spirit behind the show—a reminder that true mastery comes from asking questions, seeking answers, and working together. I plan to maintain the same once weekly cadence, but with a fresh content structure. Moving forward, I’ll be continue to do interviews with industry experts but will do more focused solo episodes. These solo episodes will be part of my continued effort to learn — transitioning from only asking all the questions to offering deeper analysis with guidance from people I look up to. Thank you to my esteemed guests! ???Of course, this journey wouldn’t be what it is without the incredible guests who’ve shared their expertise and insights. I want to extend a huge thank you to everyone who has joined me on the show, especially those who have come onto the show multiple times. You all are simply the best ?? ?? Larry Mager Ben Locwin Susan Neadle Chuck Ventura Marta New, PhD, MBA Devon C. Campbell Fran DeGrazio David Simoens, PMP Leonard (Leo) Eisner Monir El Azzouzi Sara Waxberg McNew Etienne Nichols Alan Stevens Rumi Young Michelle Lott, RAC Khaudeja Bano Naveen Agarwal, Ph.D. Aaron Snyder, MSc, Niedre Heckman, PhD, MPH, FRAPS Jane M. True

157 - Design Inputs that Don't Suck, Risk Controls and Problems with Verification with Chuck Ventura went live on youtube this morning! Available on all major podcasting platforms!

156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar drops at 5AM CT on October 2nd!

155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Brager Auerbach drops at 5AM CT tomorrow Weds Sept 25th!

The High Stakes of Early Misdiagnosis on Episode 154 with Devon C. Campbell

154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell drops at 5AM CT on September 18th!