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Let's Combinate - Drugs + Devices Let's Combinate - Drugs + Devices Subhi Saadeh Defiant Health Radio with Dr. William Davis Defiant Health Radio with Dr. William Davis William Davis, MD TED-Ed TED-Ed TED-Ed Scotland Outdoors Scotland Outdoors BBC Radio Scotland Alexis Investigates l Facts First. Clarity Always. Alexis Investigates l Facts First. Clarity Always. Alexis Knight | Facts First. Clarity Always. The Intergalactic Space Travellers Journal The Intergalactic Space Travellers Journal TTG Music Lab AI Talks with Bone & Joint AI Talks with Bone & Joint AI Talks with Bone & Joint R2Kast - People in Food and Farming/All In R2Kast - People in Food and Farming/All In Wallace Currie Cuentos y Leyendas de Honduras Cuentos y Leyendas de Honduras Cuentos y Leyendas de Honduras Ghost Town: Strange History, True Crime, & the Paranormal Ghost Town: Strange History, True Crime, & the Paranormal Ghost Town PBS Space Time PBS Space Time PBS Gordon's Lebanon Weather Forecast Gordon's Lebanon Weather Forecast Gordon's Lebanon Forecast 121523 Agriculture Today Agriculture Today Kansas State University Real Ghost Stories Online Real Ghost Stories Online Real Ghost Stories Online | Paranormal, Supernatural & Horror Radio Creepypasta zum Einschlafen Creepypasta zum Einschlafen Dr. Zargota Rebel Economics with Professor Steve Keen Rebel Economics with Professor Steve Keen Professor Steve Keen Anatomy and Physiology - Bit by Bit Anatomy and Physiology - Bit by Bit Anatomy & Physiology - Bit by Bit Strange and Unexplained Strange and Unexplained Cristina Gomez Eye On The Sky Eye On The Sky Vermont Public Logically Answered Logically Answered Logically Answered Unleashing Intuition Secrets Unleashing Intuition Secrets Michael Jaco Sea Change Sea Change WWNO & WRKF The Healthy Enterprise The Healthy Enterprise Heath Fletcher Tommy Cullum's Let's Get Freaky Tommy Cullum's Let's Get Freaky Tommy Cullum Perspectives: A Canadian Journal of Political Economy and Social Democracy Perspectives: A Canadian Journal of Political Economy and Social Democracy Broadbent Institute Dark Mysteries — Unsolved Mysteries. Forgotten Secrets. Unanswered Questions. Dark Mysteries — Unsolved Mysteries. Forgotten Secrets. Unanswered Questions. Darkest Mysteries Online Rádio Laranja Rádio Laranja Willians Fernandes Autism Live Autism Live Autism Network ® UMN Extension Nutrient Management Podcast UMN Extension Nutrient Management Podcast University of Minnesota Extension Gorilla Radio Show Gorilla Radio Show Gorilla Radio Podcast Network The Real Truth About Health Free 17 Day Live Online Conference Podcast The Real Truth About Health Free 17 Day Live Online Conference Podcast Lloyd Burrell, Keith Block M.D., Jeffrey Smith, Michael Klaper M.D., Ralph Moss, Brenda Davis R.D., Mark Sloan, Gerald Posner, Ian Harris M.D., Neil Barnard M.D., Will Tuttle Ph.D., John McDougall M.D., Pam Popper Ph.D., Gabriel Cousens M.D., Brian Clement Ph.D., Anna Maria Clement Ph.D., Marianne Williamson, Vandana Shiva Ph.D., Aly Cohen M.D., Milton Mills M.D., Theodora Scarato, William Li M.D., David Katz M.D., Stephanie Seneff Ph.D., Julieanna Hever M.S., Dale Bredesen M.D., Hope Bohanec, Kim Williams M.D., Joel Kahn M.D., Michelle Perro M.D., David Wolfe, Melanie Joy Ph.D., Sunil Pai M.D., Baxter Montgomery M.D., Michael Greger M.D., Caldwell Esselstyn M.D., Joel Fuhrman M.D., Colin Campbell Ph.D. Thrilling Threads - Conspiracy Theories, Strange Phenomena, True Crime, Unsolved Mysteries, etc! Thrilling Threads - Conspiracy Theories, Strange Phenomena, True Crime, Unsolved Mysteries, etc! Byte & Pieces Lorekeeper's Librarium Lorekeeper's Librarium Tobias Weaver El colegio invisible El colegio invisible OndaCero A hombros de gigantes A hombros de gigantes Radio 5 Ö1 Wissen aktuell Ö1 Wissen aktuell ORF Ö1 Astronomy Daily: Space News Updates Astronomy Daily: Space News Updates bitesz.com
Let's Combinate - Drugs + Devices

Ciencia

Let's Combinate - Drugs + Devices

Subhi Saadeh

246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)

July 15, 2026 5:00am 8 min

Most discussions about One QMS focus on harmonization.But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organizations structure a...

245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector

July 08, 2026 5:00am 45 min

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and what it takes to bui...

244 - 5 Critical Quality Differences Between Drugs and Devices

July 01, 2026 5:00am 8 min

Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same and highlights five ke...

243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

June 24, 2026 5:00am 14 min

Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-sessionFinished medical devices can create a lot of surprises when they are added to combination product kits.A needle, vial adapter, filter, or t...

242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start

June 17, 2026 5:00am 12 min

One of the hardest parts of auditing is not knowing what to look for.It is deciding where to start. Do you trace a deviation? Walk the process? Focus on one department? Audit CAPA across the organization? Or pull on a th...

241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?

June 10, 2026 5:00am 10 min

In this final episode of the ICH Quality series, we walk through the most important concepts in ICH Q14 and how they fit into the broader ICH quality framework.Rather than reviewing the guideline section by section, this...

240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

June 03, 2026 5:00am 11 min

ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances and drug products.Lea...

239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

May 27, 2026 7:24am 10 min

In this episode, Subhi breaks down ICH Q12, the guideline focused on post-approval change management and pharmaceutical product lifecycle management.The core question behind ICH Q12 is simple: once a product is approved,...

239 - ICH Q11 in 6 Minutes

May 20, 2026 5:00am 6 min

In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled.He places Q11 in context with Q7 for API GMP, Q8 ...

238 - 6 Audit Strategies Every Auditor Should Know

May 13, 2026 5:00am 10 min

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and DiscoveryCourse Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseIn this episode, Subhi explains why ...

237 - ICH Q10: The Pharmaceutical Quality System

May 06, 2026 5:00am 8 min

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style standard. Instead, ...

236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

April 29, 2026 5:00am 12 min

ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how it’s different from I...

235 - ICH Q8: How Pharmaceutical Development Actually Works

April 22, 2026 5:00am 10 min

This episode continues the ICH Quality Series with an overview of ICH Q8 (Pharmaceutical Development), focusing on what it is, how it’s structured, and how to think about it in practice.ICH Q8 defines the suggested conte...

234 - ICH Q7: The GMP Framework for API Manufacturing

April 15, 2026 5:00am 13 min

In this episode of Let’s Combinate, Subhi breaks down ICH Q7. Unlike topic-specific guidelines, Q7 covers the full GMP framework for API manufacturing. This episode walks through how to actually read it and what matters ...

233 - Most Teams Misunderstand Specifications | ICH Q6

April 08, 2026 5:00am 6 min

ICH Q6 Explained: Specifications, Control Strategy, and What’s Changing in Q6(R1)In this episode of Let’s ComBinate, Subhi continues the ICH Q-series with ICH Q6 and explains why specifications are central to defining an...

232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk

April 01, 2026 5:00am 34 min

Subhi Saadeh interviews Lucas Pianegonda, founder of Grad and a plastics expert in medical technology, on how medtech companies actually choose materials—and where it goes wrong. Many teams default to “we’ve always used ...

231 - Audit Findings Explained: Nonconformity vs Observation (CQA)

March 25, 2026 5:00am 11 min

This is a lesson out of my ASQ CQA course with Andy Robertson, on how to write and classify audit findings.Access the full CQA course here: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseI break down key t...

230 - How Pharma Misses Critical Market Signals with Joe Luminiello

March 22, 2026 10:14pm 30 min

In this episode of Let’s ComBinate, Subhi Saadeh sits down with Joseph Luminiello, CEO and Co-Founder of RCG Intel, to break down how competitive intelligence is actually used in biopharma and why most companies get it w...

229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products

March 11, 2026 5:00am 31 min

In this episode of Let’s Combinate, Subhi Saadeh speaks with Jen Riter about analytical method validation for drug device combination products. The discussion explores how traditional drug analytical validation under ICH...

228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently

March 04, 2026 7:00am 6 min

Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in living systems where p...

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