Podcast
Let's Combinate - Drugs + Devices
Hosted by Subhi Saadeh · EN
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!
41episodes
Episodes
Newest firstAll episodes
248 - What Is a Quality Unit? QA vs. QC Explained
1w ago00:08:54Tap to summarizeWhat 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.CHAPTERS00:00 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.comSchedule an introductory call:https://calendly.com/letscombinate/let-s-combinate-intro-sessionConnect with Subhi on LinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21Listen to Let’s Combinate on Apple Podcasts:https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792Listen on Spotify:https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2
Transcribe →247 - Why Everyone in Pharma and MedTech Should Work in Quality
2w ago00:08:17Tap to summarizeQuality 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 Matters00:35 Why Work in Quality01:41 Reason One: Learn How the Business Works02:47 Reason Two: Make Defensible Decisions05:23 Reason Three: Influence Without Authority07:43 Key TakeawaysAbout SubhiSubhi 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.
Transcribe →246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)
3w ago00:08:56Tap to summarizeMost 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.Timestamps00:00 Why "One QMS" Is Trending01:33 The Three Primary QMS Models01:50 Centralized QMS02:01 Decentralized QMS02:28 Federated (Hybrid) QMS03:50 Comparing the Document Hierarchy04:14 Centralized Document Structure05:04 Decentralized Document Structure05:22 Federated Standards, SOPs, and Governance06:50 The QMS Tree: Philosophy, Governance, and Execution08:20 Why Governance Matters More Than the ModelSubhi 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.
Transcribe →245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector
Jul 800:45:12Tap to summarizeIn 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.Chapters00:00 Meet Julia Anthony01:04 Living Without Cortisol02:03 The 14-Step Injection05:01 Building a Combination Product07:54 From Device Concept to Pharma Company10:06 Needles, Steps, and Testing13:25 Patient Insights and Human Factors16:58 Real-World Access Challenges21:50 Why Not a Liquid Formulation?24:15 Regulatory Pathway: 505(b)(2)25:13 Manufacturing and Partner Trust27:32 Rare Disease and Supplier Power31:53 Platform Vision Beyond Adrenal Insufficiency38:05 Reconstitution Is the Hard Part41:12 COVID Tailwinds and Timeline43:38 Where to Find Solution Medical44:42 Final Thoughts on CortisolAbout SubhiSubhi 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.
Transcribe →244 - 5 Critical Quality Differences Between Drugs and Devices
Jul 100:08:49Tap to summarizeDownload 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 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 evidenceDevelopment approachRisk managementRegulatory submission focusLifecycle management and change controlThe 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.Chapters00:00 Drugs vs. Devices: Why Quality Differs00:20 Intro and Practical Guide00:50 Quality Philosophy and Evidence02:27 Development Approach Differences03:56 Risk Management Mindsets05:48 Regulatory Submission Focus06:23 Lifecycle and Change Control08:03 Summary and Next StepsSubhi 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.
Transcribe →243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work
Jun 2400:14:38Tap to summarizeChat 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 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 helpThe 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 Stakes02:05 Common Supplier Myths03:54 Inheriting the Device QMS04:53 Three Crucial Moments05:51 Before Selection: Intended Use07:21 Packaging, Markets, and Risk Flags08:55 During Selection: Set Expectations10:33 Qualification: Use a Structured PPAP Approach14:12 Wrap Up and Next StepsSubhi 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
Transcribe →242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start
Jun 1700:12:10Tap to summarizeOne 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. Tracing2. Process Approach3. Process-Based Management4. Department Method5. Element Method6. Discovery MethodThese 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-sessionLearn more about Let’s Combinate:https://letscombinate.comPreparing for the CQA exam?Check out the CQA Master Class here:https://cqeacademy.teachable.com/p/the-cqa-master-class-courseChapters:00:00 Six Audit Strategies Overview01:12 Tracing Method Explained02:59 Process Approach Workflow04:27 Process-Based Management05:46 Department Method Deep Dive06:27 Element Method Across the QMS07:12 Discovery Method: Pull the Thread08:55 Summary: Pros and Cons11:31 Final Tips and Next StepsSubhi 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
Transcribe →241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?
Jun 1000:10:29Tap to summarizeIn 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.Chapters00:00 – Intro and ICH Q14 vs. Q201:08 – The Analytical Target Profile (ATP)04:16 – The Analytical Procedure Lifecycle05:32 – Risk-Based Development and Enhanced Approaches06:20 – Where ICH Q2 Fits: Validation08:04 – Connecting Q14 to ICH Q12 and Lifecycle Management09:22 – Closing the ICH Quality SeriesIn 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 boxIf 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
Transcribe →240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy
Jun 300:11:08Tap to summarizeICH 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.Learn more:https://www.letscombinate.comSchedule a call:https://calendly.com/letscombinate/let-s-combinate-intro-sessionIn this episode, Subhi Saadeh explains ICH Q13 and the key concepts behind continuous manufacturing in pharmaceutical manufacturing.The core question behind ICH Q13 is simple:How do you apply traditional quality concepts like batch definition, traceability, control strategy, validation, release, and lifecycle management when the manufacturing process does not stop?This episode covers the major Q13 concepts, including the difference between batch and continuous manufacturing, how batches can be defined in continuous manufacturing, the three continuous manufacturing models described in the guideline, residence time distribution (RTD), disturbance handling, control strategy, validation, release, and lifecycle management.Subhi also discusses why batches still matter in continuous manufacturing. Even when a process operates as a continuous flow, batches remain essential for traceability, investigations, trending, stability programs, release decisions, and recalls.Key topics covered:• What ICH Q13 is and why it matters• Batch manufacturing versus continuous manufacturing• Why manufacturers still need batch definitions• Time-based, mass-based, and campaign-based batch definitions• The three continuous manufacturing models described in ICH Q13• Residence Time Distribution (RTD)• Why RTD matters for traceability and investigations• Disturbance impact assessment and material disposition• Control strategy considerations for startup, steady-state operation, and disturbances• The role of Process Analytical Technology (PAT)• Disturbance management using magnitude, duration, and frequency• Validation considerations for continuous manufacturing• Release strategies supported by process understanding and monitoring• Lifecycle management and risk-based change controlTimestamps:00:00 ICH Q13 Overview00:48 Why Batches Matter01:21 Batch vs. Continuous Manufacturing01:59 Defining Batches02:48 Three Continuous Manufacturing Models03:54 Residence Time Distribution (RTD)06:05 Control Strategy Basics07:19 Disturbance Handling08:19 Validation, Release, and Lifecycle Management10:16 Wrap-Up and Next StepsSource referenced in this episode:ICH Q13: Continuous Manufacturing of Drug Substances and Drug ProductsFinal version adopted 16 November 2022https://database.ich.org/sites/default/files/ICH_Q13_Step4_Guideline_2022_1116.pdfReferences to ICH Q13 guideline and are included for educational commentary and discussion.Questions or feedback?📧 [subhi@letscombinate.com](mailto:subhi@letscombinate.com)🌐 https://www.letscombinate.comSubhi 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, manufacturing, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across Pfizer, Gilead Sciences, and Baxter, supporting the development and launch of vaccines, biologics, generics, medical devices, and drug-device combination products.
Transcribe →239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes
May 2700:10:45Tap to summarizeIn 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, what is actually binding, what is supporting information, and how should future changes be managed?This episode covers the major Q12 concepts, including reporting categories, Established Conditions, supporting information, Post-Approval Change Management Protocols, the Product Lifecycle Management document, and the role of the Pharmaceutical Quality System.Subhi also discusses why Q12 matters for drug-device combination products, where lifecycle changes may involve CMC information, device constituent parts, functional performance characteristics, and the broader control strategy.Key topics covered:Why post-approval change can become difficult after approvalHow ICH Q12 supports more predictable lifecycle managementReporting categories for post-approval CMC changesEstablished Conditions versus supporting informationExamples of EC candidates, including CQAs, CPPs, material attributes, methods, sites, and process informationWhy overcommitting or undercommitting ECs creates lifecycle riskHow PACMPs help companies plan future changesWhat belongs in the PLCM documentHow ICH Q12 applies to drug-device combination productsWhy a strong PQS is essential for making Q12 workTimestamps:00:00 Introduction to ICH Q1200:46 Why post-approval change gets difficult02:45 Reporting categories03:14 Established Conditions vs supporting information04:10 EC examples: CQAs, CPPs, methods, sites, and process information05:32 Post-Approval Change Management Protocols06:38 PLCM document08:08 Drug-device combination product callout10:11 PQS and change management10:28 Closing thoughtsQuestions or feedback? Email subhi@letscombinate.comSource referenced in this episode: ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, Final version adopted 20 November 2019. Screenshots shown in this video are from the ICH Q12 guideline and are included for educational commentary. https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdfSubhi 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, and speaker with experience across Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics.
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