Let's Combinate - Drugs + Devices

Subhi Saadeh
  • 5,0 (1)
  • Biowissenschaften
  • Wöchentlich

Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!

  1. vor 6 Tagen

    248 - What Is a Quality Unit? QA vs. QC Explained

    What is a Quality Unit and how do Quality Assurance and Quality Control fit within it? In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, medical-device, and combination-product companies. We’ll look at the Quality Unit’s major responsibilities, why QA is generally system- and process-focused, why QC is generally testing- and product-focused, and why the organizational structure varies between companies. CHAPTERS 00:00 What is a Quality Unit? 01:18 The Quality Unit as the umbrella function 01:55 Three major Quality Unit responsibilities 03:08 What functions may sit within Quality 04:08 Establishing, operating, and releasing 04:37 Quality Assurance vs. Quality Control 05:38 Common QA responsibilities 06:16 Common QC responsibilities 06:53 Why pharma and device companies look different 07:32 Drug vs. device terminology 08:06 How QC supports product release 08:26 Final QA vs. QC summary KEY TAKEAWAYS • The Quality Unit provides overall quality oversight. • QA primarily focuses on systems and processes. • QC primarily focuses on inspection, measurement, and testing. • QC testing provides essential evidence supporting product disposition. • Exact responsibilities and reporting structures vary by company and industry. How are QA and QC organized at your company? Share your experience in the comments. #QualityAssurance #QualityControl #QualityUnit #Pharma #MedicalDevices #qualitymanagement Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution. Learn more about Let’s Combinate: https://www.letscombinate.com Schedule an introductory call: https://calendly.com/letscombinate/let-s-combinate-intro-session Connect with Subhi on LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21 Listen to Let’s Combinate on Apple Podcasts: https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792 Listen on Spotify: https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2

  2. 22. Juli

    247 - Why Everyone in Pharma and MedTech Should Work in Quality

    Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of how regulated businesses actually operate. In this video, Subhi Saadeh explains three reasons everyone in the industry should consider spending time in quality: You learn how the business works. Quality follows the product across its lifecycle from development and suppliers through manufacturing, operations, regulatory changes, and post-market activities. You develop judgment. Quality professionals regularly make structured, risk-based decisions in gray areas and document those decisions so they can withstand audits, inspections, and future review. You learn to influence without owning everything. Quality is often accountable for outcomes without directly controlling every activity, which requires strong questions, clear communication, and the ability to help teams navigate competing priorities. Even if you do not spend your entire career in quality, the experience can make you a stronger decision-maker, collaborator, and leader throughout the rest of your career. 00:00 Why Quality Matters 00:35 Why Work in Quality 01:41 Reason One: Learn How the Business Works 02:47 Reason Two: Make Defensible Decisions 05:23 Reason Three: Influence Without Authority 07:43 Key Takeaways About Subhi Subhi Saadeh is a consultant, trainer, auditor, and the founder and principal of Let’s Combinate. He has spent his career across medical devices and pharmaceuticals, with experience spanning research and development, industrialization, quality systems, and combination products. Through Let’s Combinate, he helps professionals and organizations better understand the intersection of drugs, devices, quality, and regulatory requirements.

  3. 15. Juli

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

    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 QMS. In this episode, I compare centralized, decentralized, and federated (hybrid) Quality Management System models, including the trade-offs of each in terms of ownership, standardization, flexibility, governance, and decision-making. We also walk through how the document hierarchy typically differs across each model—from the Quality Policy and Quality Manual to standards, SOPs, work instructions, and records—and discuss why governance often has a greater impact on success than the operating model itself. Timestamps 00:00 Why "One QMS" Is Trending 01:33 The Three Primary QMS Models 01:50 Centralized QMS 02:01 Decentralized QMS 02:28 Federated (Hybrid) QMS 03:50 Comparing the Document Hierarchy 04:14 Centralized Document Structure 05:04 Decentralized Document Structure 05:22 Federated Standards, SOPs, and Governance 06:50 The QMS Tree: Philosophy, Governance, and Execution 08:20 Why Governance Matters More Than the Model Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

  4. 8. Juli

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

    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 build a drug-device combination product from a patient need. Julia was born with salt-wasting congenital adrenal hyperplasia, a life-threatening form of adrenal insufficiency. Because her body cannot make cortisol, she takes cortisol replacement daily and may need an emergency hydrocortisone injection during a crisis. The problem? The current emergency injection can take upto 14 steps to prepare, mix, and administer. Julia explains why the liquid and powder need to stay separate for stability, why the current process is so difficult during an emergency, and how Solution Medical is developing a proprietary dual-chamber primary container to simplify reconstitution while maintaining shelf life without refrigeration. We also discuss how the company evolved from a device idea into a drug-led 505(b)(2) NDA program, the development of a four-step prefilled syringe and two-step auto-injector, human factors testing with both patients and injection-naive users, manufacturing challenges in aseptic processing, supplier trust, regulatory strategy, and the broader platform potential for other mix-before-inject drugs. Chapters 00:00 Meet Julia Anthony 01:04 Living Without Cortisol 02:03 The 14-Step Injection 05:01 Building a Combination Product 07:54 From Device Concept to Pharma Company 10:06 Needles, Steps, and Testing 13:25 Patient Insights and Human Factors 16:58 Real-World Access Challenges 21:50 Why Not a Liquid Formulation? 24:15 Regulatory Pathway: 505(b)(2) 25:13 Manufacturing and Partner Trust 27:32 Rare Disease and Supplier Power 31:53 Platform Vision Beyond Adrenal Insufficiency 38:05 Reconstitution Is the Hard Part 41:12 COVID Tailwinds and Timeline 43:38 Where to Find Solution Medical 44:42 Final Thoughts on Cortisol About Subhi Subhi Saadeh is a consultant, trainer, and auditor focused on quality, regulatory, manufacturing, and supplier challenges for drugs, devices, and combination products. Through Let’s Combinate, Subhi helps companies navigate the messy intersection of pharmaceutical and medical device requirements through consulting, training, audits, and practical education. He also hosts Let’s Combinate: Drugs + Devices, where he speaks with leaders building, regulating, manufacturing, and improving combination products.

  5. 1. Juli

    244 - 5 Critical Quality Differences Between Drugs and Devices

    Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2 In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same and highlights five key areas where they differ for combination products. Drug quality often focuses on consistently remaking the product that was proven clinically, using critical quality attributes, specifications, analytical methods, stability, process validation, and batch release. Device quality emphasizes design robustness and intended use through design controls and product realization, from user needs and design inputs to validation and design transfer. This episode covers five major differences: Quality philosophy and evidence Development approach Risk management Regulatory submission focus Lifecycle management and change control The goal is not to force one system onto the other. The goal is to understand the differences early enough to intentionally integrate drug and device quality across development, manufacturing, regulatory strategy, and lifecycle management. Chapters 00:00 Drugs vs. Devices: Why Quality Differs 00:20 Intro and Practical Guide 00:50 Quality Philosophy and Evidence 02:27 Development Approach Differences 03:56 Risk Management Mindsets 05:48 Regulatory Submission Focus 06:23 Lifecycle and Change Control 08:03 Summary and Next Steps Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device quality, regulatory expectations, and practical execution.

  6. 24. Juni

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

    Chat with Subhi: https://calendly.com/letscombinate/let-s-combinate-intro-session Finished medical devices can create a lot of surprises when they are added to combination product kits. A needle, vial adapter, filter, or transfer device may already be sterile, cleared, qualified, and sold at massive scale. But already on the market does not automatically mean ready for your combination product. In this episode, I talk through the challenges of selecting finished medical devices for combination product kits and the three lifecycle moments that usually determine whether qualification goes smoothly or turns into a late-stage problem. We cover: * Why “already approved” does not mean combination-product ready * Why you inherit the supplier’s design, QMS, packaging, validation, change control, and outsourcing decisions * What to think about before supplier selection * How to set expectations during supplier selection * Why structured qualification matters * How PPAP concepts like process flow, PFMEA, control plans, inspections, sampling, and validation evidence can help The main point: A commercially available device may be qualified for someone else’s intended use. Your job is to determine whether it is qualified for yours. Chapters: 00:00 Device Selection Stakes 02:05 Common Supplier Myths 03:54 Inheriting the Device QMS 04:53 Three Crucial Moments 05:51 Before Selection: Intended Use 07:21 Packaging, Markets, and Risk Flags 08:55 During Selection: Set Expectations 10:33 Qualification: Use a Structured PPAP Approach 14:12 Wrap Up and Next Steps Subhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics. Let’s Combinate helps teams develop and control drug-device combination products by aligning quality systems, development, supplier quality, and regulatory expectations across drug and device domains. #CombinationProducts #MedicalDevices #PharmaQuality #SupplierQuality #DrugDeviceCombinationProducts #PPAP #QualitySystems

  7. 17. Juni

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

    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 thread that does not quite make sense? In this video, Subhi walks through six audit strategies from the ASQ Certified Quality Auditor Body of Knowledge and explains how they apply in real-world pharma, biotech, and combination product audits. The six strategies covered are: 1. Tracing 2. Process Approach 3. Process-Based Management 4. Department Method 5. Element Method 6. Discovery Method These approaches are useful whether you are auditing a supplier, a manufacturing site, a testing laboratory, or a quality system that spans drug, device, and combination product responsibilities. Need support with combination product quality, auditing, supplier quality, or quality system strategy? Schedule a Let’s Combinate intro call: https://calendly.com/letscombinate/let-s-combinate-intro-session Learn more about Let’s Combinate: https://letscombinate.com Preparing for the CQA exam? Check out the CQA Master Class here: https://cqeacademy.teachable.com/p/the-cqa-master-class-course Chapters: 00:00 Six Audit Strategies Overview 01:12 Tracing Method Explained 02:59 Process Approach Workflow 04:27 Process-Based Management 05:46 Department Method Deep Dive 06:27 Element Method Across the QMS 07:12 Discovery Method: Pull the Thread 08:55 Summary: Pros and Cons 11:31 Final Tips and Next Steps Subhi Saadeh is the Founder and Principal of Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across pharma, biotech, medical devices, and combination products. #Pharma #Biotech #Quality #Auditing #QualityAudits #CQA #GMP #CombinationProducts #QualitySystems #ISO13485

  8. 10. Juni

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

    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 episode focuses on the ideas that are most useful in practice: Why does ICH Q14 start with the Analytical Target Profile (ATP)? How is it different from ICH Q2? How do you develop analytical procedures using a science- and risk-based approach? And what does all of this have to do with ICH Q12 and lifecycle management? One quick note: at the time of recording, ICH Q14 remains under public comment, so some details may evolve before the final version is adopted. Chapters 00:00 – Intro and ICH Q14 vs. Q2 01:08 – The Analytical Target Profile (ATP) 04:16 – The Analytical Procedure Lifecycle 05:32 – Risk-Based Development and Enhanced Approaches 06:20 – Where ICH Q2 Fits: Validation 08:04 – Connecting Q14 to ICH Q12 and Lifecycle Management 09:22 – Closing the ICH Quality Series In this episode, we cover: • Why ICH Q14 exists • The difference between ICH Q14 and ICH Q2 • What an Analytical Target Profile (ATP) is • ATP examples and performance criteria • Technology selection and fit-for-purpose methods • The analytical procedure lifecycle • Risk assessments and enhanced development approaches • Multivariate experiments and DOE concepts • Analytical procedure control strategies • Validation and the role of ICH Q2 • Lifecycle management of analytical procedures • The connection between ICH Q14 and ICH Q12 • Why understanding matters more than simply checking a box If you've followed along through the ICH Quality series, one of the themes that keeps showing up is that quality isn't something you test into products at the end. Whether we're talking about Q8, Q9, Q10, Q12, or now Q14, the emphasis continues to shift toward building knowledge, understanding risk, and using that understanding throughout the lifecycle. Subhi Saadeh is the Founder and Principal at Let's Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, speaker, and host of the Let's Combinate podcast, with experience across companies including Pfizer, Gilead, and Baxter supporting vaccines, biologics, generics, and combination products. 📅 Schedule an intro session: https://calendly.com/letscombinate/let-s-combinate-intro-session 🎙️ Let's Combinate Podcast: https://www.letscombinate.com #ICHQ14 #ICHQ2 #ICHQ12 #AnalyticalValidation #PharmaQuality #QualityByDesign #LifecycleManagement #DrugDevelopment #CombinationProducts

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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!

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