Let's Combinate - Drugs + Devices

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!

Let's Combinate - Drugs + Devices is a science podcast hosted by Subhi Saadeh, with 258 episodes on record and a Required Pod Score of 80. PitchCentric scores this show on Booking Probability, Listen Score, and live audience signals refreshed every 24 hours.

Subhi Saadeh hosts Let's Combinate - Drugs + Devices, a science show with 258 episodes published.

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  Let's Combinate - Drugs + Devices

  250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?

  Aug 12, 202611 min

  PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualification and validation are approached today. In this video, I walk through where PI 006-4 fits within the broader GMP framework, how it relates to EU Annex 15, and the sections I think are most worth paying attention to. A few of the major themes include a much stronger emphasis on quality risk management and lifecycle thinking, more explicit expectations around statistics, sampling, variability, and process capability, a move away from treating three validation batches as a default answer, and clearer discussion of traditional validation, continuous process verification (CPV), hybrid approaches, and ongoing process verification (OPV). The goal isn't to suggest that all of these concepts are brand new. Many have been developing across the industry for years. What is interesting is seeing how PIC/S has now pulled them together into an updated recommendation that reflects current qualification and validation thinking. Chapters 00:00 Big Update Overview 01:02 Who PIC/S Serves 01:28 Annex 15 Relationship 02:12 Scope and Exclusions 02:39 Why Update Now 04:05 Four Key Changes 04:47 Risk and Lifecycle Shift 06:43 Statistics and Sampling 07:48 Rethinking the Three-Batch Rule 08:30 Ongoing Process Verification 09:11 Traditional, CPV and Hybrid Approaches 10:45 Key Takeaways About Subhi 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. Connect With Let’s Combinate Website: https://www.letscombinate.com Schedule an intro call: https://calendly.com/letscombinate/let-s-combinate-intro-session LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21 Apple Podcasts: https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792 Spotify: https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2 Documents Discussed PIC/S PI 006-4 — Recommendations on Qualification and Validation (2026) https://picscheme.org/docview/11277 PIC/S PI 006-3 — Validation Master Plan, IQ/OQ, Non-Sterile Process Validation & Cleaning Validation (2007) https://picscheme.org/docview/3447 EMA / PIC/S Concept Paper — Revision of Annex 15: Qualification and Validation (2026) https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation_en.pdf PIC/S Publications Page https://picscheme.org/en/publications

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  Let's Combinate - Drugs + Devices

  249 - The Best Audit Advice Nobody Told Me

  Aug 5, 202614 min

  Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may need to improve. In this video, I share the lessons I learned as I moved from being audited and supporting audit rooms to conducting audits as a certified lead auditor: 1) Audit the system, not the person: The goal is to understand how the system operates, not to catch an individual making a mistake. 2) Look for patterns, not isolated errors: One typo is different from a recurring or systemic problem, unless the individual event is critical. 3) Scope the audit before you start: The objective, criteria, time, resources, and agenda need to align before the audit begins. 4) Technical expertise is not the same as audit skill: Auditing requires its own tools, tactics, strategies, interviewing skills, and qualification. 5) Lower the temperature to get better evidence: People communicate more clearly when the auditor reduces unnecessary anxiety, although assertiveness is sometimes necessary when information is being withheld. Chapters 00:00 Audits Aren’t Gotchas 00:38 Audit the System, Not the Person 03:16 Look for Patterns, Not Isolated Mistakes 05:27 Set a Clear Audit Scope 08:21 Auditing Is Its Own Skill and Being Technical Helps 11:11 Lower the Temperature and Be a Human About Subhi 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: https://letscombinate.com/ subhi@letscombinate.com Connect with Subhi on LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21

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  Let's Combinate - Drugs + Devices

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

  Jul 29, 20269 min

  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

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  Let's Combinate - Drugs + Devices

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

  Jul 22, 20268 min

  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.

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  Let's Combinate - Drugs + Devices

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

  Jul 8, 202645 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 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.

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