Explore every episode of the podcast Let's Combinate - Pharma + Medical Devices with Subhi Saadeh

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	Title	Pub. Date	Duration
	259 - The Career Lesson I Learned the Hard Way in Pharma	19 Oct 2026	00:05:54
Career growth in pharma and medical devices takes technical knowledge, leadership, and the ability to earn your team’s trust. In this episode, Subhi Saadeh shares a lesson from leading a drug-device combination product program that changed how he approached his career in quality. Early in my career, I was excited about getting on big projects, gaining exposure, and proving what I could do. But leading a team with deeper technical expertise than I had taught me something I had to learn the hard way: it’s not about you. I share how asking questions, following through, and helping people address their problems helped me earn their respect and become a more effective lead. In this episode: - Understanding what your team and stakeholders need from you - Leading technical experts while building your own experience - Being coachable and following through on what you learn - Applying customer focus beyond the quality system - Building credibility by helping others move their work forward - What a mentor meant by “their cookie, your crumb” Chapters: 00:00 The career lesson: It’s not about you 00:25 Career exposure and proving yourself 00:53 Why people value having you around 01:17 Customer focus in quality and leadership 02:03 Leading a complex combination product program 03:25 Feeling out of your depth 03:42 Understanding what your team needs 04:02 Being coachable and earning credibility 05:07 Rethinking career growth and success 06:10 “Their cookie, your crumb” About Subhi: Subhi Saadeh is a Quality Professional, Founder & Principal of Combinate, and host of Let’s Combinate: Drugs + Devices. With a background in Quality, Manufacturing Operations, and R&D, he has works with medical device and pharmaceutical organizations supporting the development and launch of combination products for vaccines, generics, and biologics. Subhi served as the International Committee Chair for the Combination Products Coalition (CPC) and was a member of ASTM Committee E55. He previously served on AAMI’s Combination Products Committee. He is an ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), and ISO 13485 Lead Auditor. Connect and learn more: Website: [letscombinate.com](https://letscombinate.com) LinkedIn: [Subhi Saadeh](https://www.linkedin.com/in/subhi-saadeh-1169aa21/) Email: subhi@letscombinate.com CQA Master Class: [Become a Certified Quality Auditor](https://cqeacademy.teachable.com/p/the-cqa-master-class-course) Watch and listen: [YouTube](https://www.youtube.com/@LetsCombinate) [Spotify](https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2) [Apple Podcasts](https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792) Subscribe for weekly conversations where drugs and devices meet. For questions, inquiries, or suggestions, please reach out at letscombinate.com or email subhi@letscombinate.com.
	258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin	12 Oct 2026	00:34:15
Combination product quality with Ben Locwin: why drug and device quality systems differ, how human factors studies are designed, what to do when a CDMO's clean audit doesn't match its performance, and how ISO 14971 risk management compares with ICH Q9. This conversation was recorded for Ben Locwin's Life Science Shifts podcast from Reliant Life Sciences, with Subhi Saadeh as the guest. It covers where pharma and medical device thinking diverge, and what that means when one product has to satisfy both. IN THIS EPISODE - Why drugs and devices prove safety and effectiveness in different ways - Drug development (clinical, nonclinical, CMC) vs. device design controls - Why the same syringe can need new human factors work for a different user - How human factors studies are built: patient and caregiver arms, trained and untrained users - CGMPs for combination products: QMSR, ISO 13485, ICH, and PIC/S - Global harmonization: IMDRF for devices, ICH for drugs, and the gap for combination products - CDMO oversight when the supplier scorecard and the audit result don't match what you see - ISO 14971 and ISO/TR 24971 vs. ICH Q9: initial and updated probability - FMEA as a living document TIMESTAMPS 0:00 Pharma vs. medical device quality: two philosophies 2:10 Drug development vs. device design controls 4:29 Why device trials rarely use placebo controls 9:52 Platform technology and delivery devices 12:10 Same device, different user: bracketing and generic platforms 14:14 Human factors studies: recruitment, study arms, formative studies 15:40 CGMPs for combination products: QMSR, ISO 13485, ICH, PIC/S 16:58 Harmonization: IMDRF and ICH 19:12 Conway's Law and organizational inertia 22:06 Staying objective as a consultant 25:10 CDMO oversight: when the scorecard doesn't match reality 30:18 Scoring bias in subjective weighting 31:14 ISO 14971 vs. ICH Q9 risk management 32:32 FMEA as a living document RELATED VIDEOS Pharma vs. Medical Device Quality Systems: 5 Differences https://youtu.be/xG0htEu0ph4 Working with a Device CDMO: Common Sponsor Mistakes https://youtu.be/d2SDwndXuCk ICH Q9 Explained https://youtu.be/Is67hbh71RY Design Controls Explained for Pharma and Combination Product Teams https://youtu.be/f7esiLpUhfM Need help with CDMO oversight, supplier audits, or risk management on a combination product? https://letscombinate.com/services/ ABOUT BEN LOCWIN Ben Locwin is Vice President at Reliant Life Sciences and host of the Life Science Shifts podcast. His work spans drug therapies, vaccines, and medical devices, and he is a frequent industry speaker and commentator on pharma and medical device quality. Reliant Life Sciences: https://www.reliantlifesciences.com/ ABOUT SUBHI SAADEH Subhi Saadeh is the Founder and Principal of Let's Combinate, a consultant, auditor, and trainer specializing in drug-device combination products, medical devices, and pharmaceutical quality systems. He has held quality and engineering roles at Pfizer, Gilead, and Baxter, with experience spanning quality, R&D, and commercialization and a focus on design controls, supplier quality, inspection readiness, and translating regulatory expectations into practical execution. Subhi is an ISO 13485 Lead Auditor and an ASQ Certified Quality Auditor and Certified Quality Engineer. He has chaired the Combination Product Working Group for Rx-360, served as International Committee Chair for the Combination Products Coalition (CPC) and as a member of ASTM Committee E55, and served on AAMI's Combination Products Committee. CONNECT WITH SUBHI Consulting, audits, and training: https://letscombinate.com/services/ Discuss a project: https://calendly.com/letscombinate/quick-chat LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/ Email: subhi@letscombinate.com FOLLOW LET'S COMBINATE YouTube: https://www.youtube.com/@LetsCombinate Spotify: https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2 #CombinationProducts #HumanFactors #RiskManagement
	257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products	05 Oct 2026	00:12:57
21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 Subpart A section by section: the scope, the key definitions, which CGMPs apply, and the two ways to comply, including the streamlined approach under 4.4(b). Updated for February 2026, when the device side moved to the QMSR and ISO 13485, plus the new medical gas provisions. Working on your first combination product program? Watch this next: https://youtu.be/uG_Ea__-Pjc Want a second set of eyes on your combination product quality system? Book a quick call: https://calendly.com/letscombinate/quick-chat Sources 21 CFR Part 4 (eCFR): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4 FDA Guidance, CGMP Requirements for Combination Products: https://www.fda.gov/media/90425/download Chapters 0:00 Intro 0:50 21 CFR Part 4 Subpart A vs. Subpart B 2:00 Full compliance vs. the streamlined approach 2:39 21 CFR 4.1: Scope (single-entity and co-packaged) 3:52 21 CFR 4.2 and 4.3: Definitions and which CGMPs apply 4:37 21 CFR 4.4: How to comply with CGMPs for combination products 5:38 Drug-based system: ISO 13485 and QMSR provisions to add 7:58 Device-based system: 21 CFR 211 provisions to add 11:24 Medical gas and 4.4(c)–(e): separate facilities 12:10 Wrap-up About me I'm Subhi Saadeh. I help companies make drug and device quality systems work together. I'm a consultant, auditor, and trainer focused on combination products, an ISO 13485 Lead Auditor, and an ASQ CQA and CQE. I've worked on prefilled syringes, autoinjectors, IV bags, cartridges, and vial-based systems, from clinical through commercial. 🌐 https://letscombinate.com 📅 https://calendly.com/letscombinate/quick-chat 💼 https://www.linkedin.com/in/subhi-saadeh-1169aa21 ✉️ subhi@letscombinate.com #CombinationProducts #21CFRPart4 #QMSR
	256 - The New FDA Inspection Playbook: Where to Start with QMSR	28 Sep 2026	00:09:29
QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382.850. What does that mean for industry and how should we use the new program to prepare? In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh introduces a four-part series on QMSR inspection readiness. We compare QSIT’s four major inspection subsystems with the new program’s six QMS areas, explore how risk informs inspection coverage, and identify where industry should start reading. The episode also features an excerpt from Subhi’s conversation with Eric Pittman, a former FDA investigator who spent a decade as editor-in-chief of FDA’s Investigations Operations Manual. IN THIS EPISODE • What replaced QSIT and where to find it • Why Part III is a useful starting point for industry • How FDA reorganized inspection coverage into six QMS areas • How product risks and risk management documentation help guide record selection • What’s coming in the QMSR inspection readiness series TIMESTAMPS 00:00 QSIT is gone: What changed with QMSR 00:50 The new FDA inspection program 01:39 The four-part inspection readiness series 02:47 Eric Pittman: Where industry should start 04:14 Will FDA publish a new QSIT guide? 05:06 Comparing the old and new inspection approaches 05:47 Four major subsystems to six QMS areas 06:57 Inspection models and record selection 07:37 Risk, controls, and inspection evidence 08:08 What’s next in the series THE SERIES 1. QSIT to QMSR: Understanding the new inspection program 2. Inspection models, coverage, and record selection 3. The six QMS areas and how they connect 4. Inspection readiness: Preparing people, processes, and records, with lessons from early QMSR warning letters RESOURCES FDA Compliance Program 7382.850 — Inspection of Medical Device Manufacturers Part III begins on page 20. Attachment A details the QMS areas, elements, and requirements. https://www.fda.gov/media/80195/download FDA Investigations Operations Manual — Chapter 5 https://www.fda.gov/media/166533/download FDA QMSR Frequently Asked Questions https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions ABOUT SUBHI SAADEH Subhi Saadeh is the Founder and Principal of Let’s Combinate, a consultant, auditor, and trainer specializing in drug-device combination products, medical devices, and pharmaceutical quality systems. His experience spans quality, R&D, and commercialization, with a focus on design controls, supplier quality, inspection readiness, and translating regulatory expectations into practical execution. Subhi is an ISO 13485 Lead Auditor and an ASQ Certified Quality Auditor and Certified Quality Engineer. CONNECT WITH SUBHI Consulting, audits, and training: https://letscombinate.com LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/ Schedule a quick chat: https://calendly.com/letscombinate/quick-chat Email: subhi@letscombinate.com FOLLOW LET’S COMBINATE YouTube: https://www.youtube.com/@LetsCombinate Spotify: https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2 Apple Podcasts: https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792
	255 - Audit Interview Techniques: How Good Auditors Get Better Evidence	21 Sep 2026	00:11:30
A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In this episode, I pulled one of the lessons from the auditing course Andy Robertson and I developed and walk through some of the fundamentals of audit interviewing: building rapport, asking open-ended questions, avoiding overly checklist-driven interviews, corroborating information, managing group interviews and translators, and handling some of the situations that make interviews difficult.If documents and records alone were enough to understand the quality of an organization, every audit could be a desktop audit. People are a huge part of what makes an audit work.Full CQA Master Class:https://cqeacademy.teachable.com/p/the-cqa-master-class-courseChapters0:00 Intro1:39 Interviewing Fundamentals3:04 Conversational vs. Checklist3:49 Building Rapport4:29 Focus on the Process5:30 Open-Ended Questions5:58 Corroborating Information6:44 Group Interviews7:29 Using Translators8:20 Interview Challenges10:29 Time Management11:16 ClosingAbout SubhiSubhi 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.Learn more about Let’s Combinate:https://letscombinate.com/Connect with Subhi on LinkedIn:https://www.linkedin.com/in/subhi-saadeh-1169aa21Need help?https://calendly.com/letscombinate/let-s-combinate-intro-session#Quality #Auditing #QualityAssurance #CQA #Pharma #MedicalDevices #CombinationProducts
	254 - Saying No Is the Easy Part of Quality	13 Sep 2026	00:12:25
Quality has a reputation for saying no. Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer. In this episode, Subhi breaks down four situations where Quality should absolutely stop the train, and a few where it’s worth stepping back and asking what’s really driving the no in the first place. Subhi covers: when there is real patient or product risk when the evidence doesn’t support the decision when moving forward would clearly violate requirements or SOPs when schedule or business pressure is pushing a team to close something that isn’t actually closed He also talks through some weaker reasons Quality says no, including: personal preference or “this is how we’ve always done it” uncertainty from lack of technical familiarity applying more GMP rigor than the stage of development actually requires If you work in quality, combination products, development, manufacturing, or technical leadership, this is a practical look at how to think about “no” in a more risk-based way. Timestamps 00:00 Why Quality Says No 00:45 Channel Intro and Setup 02:02 No When Risk Is Real 03:06 No When Evidence Fails 05:02 No When Requirements Break 05:44 No to Schedule Pressure 07:48 Bad No From Preference 08:33 Bad No From Uncertainty 09:20 Overkill and Phase GMPs 10:08 Build Flexible Quality Culture 12:16 Wrap Up and Takeaways 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 and navigate the intersection of drugs, devices, quality, and regulatory requirements. Connect with Subhi Saadeh LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/ Website: http://letscombinate.com/ Book a quick chat: https://calendly.com/letscombinate/quick-chat Email: subhi@letscombinate.com Listen / Follow Let’s Combinate YouTube: https://www.youtube.com/@LetsCombinate Spotify: https://open.spotify.com/show/71wYadhCrfLsdYTVachpD2 Apple Podcasts: https://podcasts.apple.com/us/podcast/lets-combinate-drugs-devices/id1589285792 #Quality #CombinationProducts #Pharma #MedTech #RiskManagement #GMP #DesignControls #SupplierQuality #QualitySystems #LetsCombinate
	253 - FDA Is Making Big Changes to Its Inspection Approach	07 Sep 2026	00:45:53
FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model. Eric Pittman spent more than 20 years at FDA, conducted approximately 800+ inspections, led the Bioresearch Monitoring Division West, and served for a decade as editor-in-chief of FDA’s Investigations Operations Manual. In this episode, Eric explains how FDA investigators are trained to think, the difference between technical expertise and inspection skill, why investigators sometimes “phone home,” and what the transition from ORA to OII means for the agency’s inspection model. We also discuss BIMO inspections, the difference between inspections and investigations, the end of QSIT, and how companies can use FDA’s Investigations Operations Manual and compliance programs to prepare more effectively. Timestamps 00:00 Introduction 00:48 FDA’s generalist and specialist inspection models 03:52 What is Bioresearch Monitoring (BIMO)? 05:03 What makes someone an effective FDA investigator? 08:39 Technical expertise versus auditing and inspection skills 11:25 What FDA investigators are actually looking for 14:07 Eric’s experience conducting 800–1,000 inspections 15:11 How investigators prepare, inspect, and write reports 19:44 Why FDA investigators sometimes “phone home” 23:35 The transition from ORA to OII 28:00 What responsibilities remain within OII? 30:31 FDA inspections versus investigations 33:05 The IOM, QSIT, and investigator discretion 38:25 How industry should use FDA compliance programs 44:13 What companies waste time preparing for 45:55 Where to find Eric About Eric Pittman Eric Pittman is Vice President of Quality Assurance and Regulatory Affairs at Project Farma. Before moving into industry, he spent more than 20 years at FDA across drugs, devices, foods, biologics, and bioresearch monitoring. He served as Division Director for Bioresearch Monitoring West, was the U.S. delegate to the OECD Working Party on Good Laboratory Practice, and spent a decade as editor-in-chief of FDA’s Investigations Operations Manual. Eric is also an adjunct professor in Temple University’s QA/RA graduate program. Connect with Eric LinkedIn: https://www.linkedin.com/in/ericspittmanmba-fda Project Farma: https://projectfarma.com About Subhi Saadeh Subhi Saadeh is a combination-product quality professional, consultant, and host of Let’s Combinate: Drugs + Devices. His work focuses on the intersection of pharmaceutical and medical-device requirements, including combination-product quality systems, design controls, supplier quality, manufacturing, inspection readiness, and regulatory strategy. Through Let’s Combinate, Subhi brings together regulators, industry leaders, and technical experts to make complex drug-device topics easier to understand and apply. Connect with Subhi LinkedIn: https://www.linkedin.com/in/subhi-saadeh-1169aa21/ YouTube: https://www.youtube.com/@LetsCombinate Website: https://letscombinate.com
	252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)	31 Aug 2026	00:13:06
Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality. In this video, I break down the fundamentals of acceptance sampling: what it is, what an AQL actually means, the difference between sampling by attributes and variables, and the risk involved when we use a sample to make an accept/reject decision about an entire lot. We’ll also introduce Operating Characteristic (OC) curves, producer risk, and consumer risk — because acceptance sampling is probability-based and every sampling plan comes with tradeoffs. This is the first video in a series on acceptance sampling. Future videos will go deeper into attribute sampling, variable sampling, and how to select and apply sampling plans in practice. Topics Covered: * What acceptance sampling is * Why acceptance sampling is probability-based * AQL — Acceptance Quality Limit * Why AQL does not simply mean “allowable percent defective” * Attribute vs. variable acceptance sampling * ISO 2859-1 / ANSI-ASQ Z1.4 * ISO 3951 / ANSI-ASQ Z1.9 * Operating Characteristic (OC) curves * Producer risk vs. consumer risk * How overly tight or overly loose sampling plans can create problems Chapters 00:00 Introduction 01:30 Why Acceptance Sampling Matters 01:45 Perfect World vs. Reality 02:49 What Is Acceptance Sampling? 03:53 Attributes vs. Variables 05:21 What Is AQL? 07:05 Risk & the OC Curve 09:57 Producer & Consumer Risk 12:05 Practical Takeaway About Subhi Saadeh Subhi Saadeh is the Founder and Principal of Let’s Combinate, an independent media, education, and consulting company focused on drug device combination products, quality systems, and quality engineering. Subhi is a consultant, trainer, and auditor with a background spanning R&D, industrialization, commercialization, and quality across the pharmaceutical and medical device industries. He is also the host of Let’s Combinate: Drugs + Devices where he talks with industry leaders and breaks down complex quality, regulatory, device, pharma and combination-product topics. Need help with consulting, training, or auditing? Learn more at: [https://www.letscombinate.com](https://www.letscombinate.com) Connect with Subhi: LinkedIn: [https://www.linkedin.com/in/subhi-saadeh-1169aa21](https://www.linkedin.com/in/subhi-saadeh-1169aa21) Email: [subhi@letscombinate.com](mailto:subhi@letscombinate.com) #AQL #AcceptanceSampling #QualityEngineering #Pharma #MedicalDevices #CombinationProducts #ISO2859 #ISO3951
	251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy	24 Aug 2026	00:49:29
In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug delivery device market is headed and what it takes for new technologies to actually make it to patients. Steven brings more than 21 years of experience across drug delivery and combination products, spanning strategy, business development, commercialization, consulting, and executive leadership. The conversation explores what makes a drug delivery device commercially successful in 2026, why pharma companies can be hesitant to adopt unproven technologies, and how device companies can differentiate in an increasingly crowded market. Steven also discusses the growth of larger-volume subcutaneous delivery, the tradeoffs between reusable and disposable devices, sustainability, primary container strategy, and the changing role of sales and business development in drug delivery. Subhi and Steven also dig into oral GLP-1s and whether oral drugs could ultimately displace injectables. Steven explains why route of administration alone does not determine the better solution — efficacy, patient adherence, cost, usability, and the overall treatment experience all matter. The episode closes with Steven looking ahead to 2035 and explaining why he believes sustainability will be one of the major forces shaping the next generation of drug delivery devices. Timestamps 00:00 Introduction and Steven’s Drug Delivery “Bookshelf” 02:24 From Marketing to Drug Delivery Strategy 06:10 What Makes a Device Commercially Successful in 2026? 11:11 Is the Large-Volume Injection Market Getting Crowded? 14:28 The Chicken-and-Egg Problem With New Device Technologies 19:25 CDAs, Proprietary Information and Working With New Suppliers 22:31 How Do You Sell a Drug Delivery Device in 2026? 29:17 Why Drug Delivery Is Still “Sexy” 31:20 Oral Drugs, Adherence and the Mucinex Horse Pill 33:18 Reusable Devices and Human Factors 35:22 Sustainability as a Drug Delivery Market Force 39:32 Cartridge vs. Prefilled Syringe 43:57 If You Had to Bet on One Drug Delivery Trend Through 2035 46:55 IV Drugs and the Shift Toward Subcutaneous Delivery 49:15 Steven’s Book Recommendation: Make Your Bed 51:22 Where to Find Steven Steven Kaufman Bio Steven Kaufman is the Founder of Combination Product Solutions, Inc. and a drug delivery and combination product executive with more than 21 years of industry experience. His career has spanned device strategy, commercialization, business development, consulting, executive leadership, and entrepreneurship. Steven has held senior roles across the drug delivery industry and today works with device companies, biotech and pharmaceutical organizations, and investors on commercialization, technology strategy, platform evaluation, and bringing new drug delivery technologies to market. Steven also serves as fractional Chief Commercial Officer at Portal Instruments. Connect with Steven Website: Combination Product Solutions Email: info@combinationproductsolutions.com LinkedIn: Steven Kaufman on LinkedIn Subhi Saadeh Bio Subhi Saadeh is a Quality Professional and host of Let’s Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large medical device and pharmaceutical organizations supporting the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics. For questions, inquiries, consulting, or episode suggestions: Website: Let’s Combinate LinkedIn: Subhi Saadeh on LinkedIn Email: subhi@letscombinate.com
	I'm Changing The Podcast	18 Aug 2026	00:02:47
After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change. Starting now, new episodes will go live Mondays at 5:00 AM CT. To everyone who watches, listens, shares, or has been part of the journey: thank you. This podcast has been one of the most enriching things I’ve ever done. See you Monday. 🌐 https://letscombinate.com 📅 https://calendly.com/letscombinate/let-s-combinate-intro-session 💼 https://www.linkedin.com/in/subhi-saadeh-1169aa21 About Subhi Saadeh Subhi Saadeh is a combination product quality and compliance professional, consultant, auditor, trainer, and host of Let’s Combinate: Drugs + Devices, where he explores the intersection of pharmaceutical and medical device quality.
	250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?	12 Aug 2026	00:11:15
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
	249 - The Best Audit Advice Nobody Told Me	05 Aug 2026	00:14:29
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
	248 - What Is a Quality Unit? QA vs. QC Explained	29 Jul 2026	00:08:54
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
	247 - Why Everyone in Pharma and MedTech Should Work in Quality	22 Jul 2026	00:08:17
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.
	246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)	15 Jul 2026	00:08:56
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.
	245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector	08 Jul 2026	00:45:12
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.
	244 - 5 Critical Quality Differences Between Drugs and Devices	01 Jul 2026	00:08:49
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.
	243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work	24 Jun 2026	00:14:38
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
	242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start	17 Jun 2026	00:12:10
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
	241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?	10 Jun 2026	00:10:29
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
	240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy	03 Jun 2026	00:11:08
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.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.
	239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes	27 May 2026	00:10:45
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, 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 approval How ICH Q12 supports more predictable lifecycle management Reporting categories for post-approval CMC changes Established Conditions versus supporting information Examples of EC candidates, including CQAs, CPPs, material attributes, methods, sites, and process information Why overcommitting or undercommitting ECs creates lifecycle risk How PACMPs help companies plan future changes What belongs in the PLCM document How ICH Q12 applies to drug-device combination products Why a strong PQS is essential for making Q12 work Timestamps: 00:00 Introduction to ICH Q12 00:46 Why post-approval change gets difficult 02:45 Reporting categories 03:14 Established Conditions vs supporting information 04:10 EC examples: CQAs, CPPs, methods, sites, and process information 05:32 Post-Approval Change Management Protocols 06:38 PLCM document 08:08 Drug-device combination product callout 10:11 PQS and change management 10:28 Closing thoughts Questions or feedback? Email subhi@letscombinate.com Source 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.pdf 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, and speaker with experience across Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics.
	239 - ICH Q11 in 6 Minutes	20 May 2026	00:06:06
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 for pharmaceutical development, Q9 for quality risk management, and Q10 for the pharmaceutical quality system. The episode covers Section 3 on manufacturing process development, Section 5 on starting materials, and Section 6 on control strategy beyond release testing. In the next episode, Subhi will cover ICH Q12. Timestamps 00:00 ICH Q11 overview 00:47 Drug substance basics 01:14 Where Q11 fits in the ICH Quality framework 02:15 Section 3: Manufacturing process development 03:26 Linking drug substance quality to drug product quality 04:25 Section 5: Starting materials 05:41 Section 6: Control strategy 06:11 Wrap-up and next episode 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, and speaker with experience across Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics.
	238 - 6 Audit Strategies Every Auditor Should Know	13 May 2026	00:10:04
Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and Discovery Course Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-course In this episode, Subhi explains why selecting the right auditing strategy matters when auditors have limited time, limited access, and a specific audit objective. He walks through six major strategies: tracing, process approach, process-based management, department method, element method, and discovery method. The episode covers how each strategy works, where it is useful, and where it can fall short. Subhi also explains why real audits rarely rely on only one method. Strong auditors know how to combine strategies based on the audit objective, the evidence being reviewed, and what the audit trail reveals. Timestamps 00:00 Six Audit Strategies Overview 00:22 Why Strategy Matters 01:13 Course Context and Setup 02:28 Tracing Method Explained 03:26 Process Approach Walkthrough 04:21 Department Method Deep Dive 05:26 Element Method Against Standards 06:12 Discovery Method String Pull 06:36 Pros, Cons, and Final Summary 09:53 Wrap Up and Next Session 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, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.
	237 - ICH Q10: The Pharmaceutical Quality System	06 May 2026	00:08:12
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, Q10 is designed to augment regional GMPs and provide a lifecycle model for managing pharmaceutical quality. Using the Annex 2 PQS diagram, Subhi walks through how Q10 applies across pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. The episode discusses phase-appropriate GMP expectations, why Q10 does not replace GMP, and how management responsibility spans the full lifecycle, including outsourced activities and purchased materials. The episode also covers the four core PQS elements: process performance and product quality monitoring, CAPA, change management, and management review. These elements are presented as operational loops that help maintain control and drive improvement. Subhi also highlights the two key enablers of the model: knowledge management, connected to ICH Q8, and quality risk management, connected to ICH Q9. The episode closes with Section 4 of Q10, which focuses on continual improvement of the PQS itself, including management review inputs, external changes, resourcing, documentation, and communication. 00:00 Welcome and Series Setup 00:14 Why ICH Q10 Matters 01:21 Lifecycle and Phase-Appropriate GMP 02:23 GMP Foundation and the PQS Model 02:58 Management Responsibility 03:31 Core PQS Elements 04:26 Enablers: Knowledge Management and QRM 04:40 Guideline Walkthrough: Sections 1 to 3 06:37 Continual Improvement of the PQS 07:45 Wrap Up and Next Episode 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, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.
	236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences	29 Apr 2026	00:12:16
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 ISO 14971. We cover: What “risk” means in ICH Q9 (probability × severity) The full QRM process (initiation → assessment → control → communication → review) How to actually think through risk (not just document it) Why supply disruption is a patient risk Key differences vs ISO 14971 (planning, traceability, verification) If you work in pharma, devices, or combination products, this is foundational. TIMESTAMPS 00:00 Welcome to ICH Q9 00:48 What is Risk in ICH Q9 01:44 Scope and Core Principles 03:21 Initiating QRM 05:09 Risk Assessment (Hazards, Likelihood, Severity) 07:27 Risk Control (Reduction and Acceptance) 08:46 Risk Communication and Review 10:04 ICH Q9 vs ISO 14971 11:51 Wrap Up ICH Q9(R1) Final Guideline: https://database.ich.org/sites/default/files/ICH_Q9-R1_Guideline_Step4_2023_0118.pdf ICH Q9 Briefing Pack: https://ich.org/page/q9r1-briefing-pack 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, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.
	235 - ICH Q8: How Pharmaceutical Development Actually Works	22 Apr 2026	00:10:49
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 contents for CTD Section 3.2.P.2 and aims to harmonize how pharmaceutical development is presented in regulatory submissions. It primarily applies to drug product development and later-stage submissions, where a full understanding of the product and process is expected. The guideline is structured in three parts: the core sections, which outline development elements such as formulation, manufacturing, and container closure; the annexes, which introduce key Quality by Design concepts including QTPP, CQAs, risk assessment, design space, and control strategy; and a final section that explains how this information is organized across the CTD. The episode walks through the relationship between TPP and QTPP, defines critical quality attributes, explains how design space is established through prior knowledge, risk assessment, and experimental work such as design of experiments, and outlines how a control strategy is built across materials, process controls, monitoring, and testing. High Level QBD(4 min): https://www.youtube.com/watch?v=orlPpfQvb5k QBD vs. Design Controls: https://www.youtube.com/watch?v=W_LSD0kKQ34 00:00 Introduction to ICH Q8 00:42 Related QbD Videos 01:12 Structure of ICH Q8 02:28 Objective and Scope 04:49 Annexes and QbD Concepts 05:20 Quality Target Product Profile 06:33 Critical Quality Attributes 07:09 Design Space and DoE 09:17 Control Strategy 10:06 Submission and Wrap-Up 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. A consultant, auditor, and trainer, Subhi has worked across companies including Baxter, Pfizer, and Gilead, supporting the development, manufacturing, and launch of medical devices and combination products for vaccines, generics, and biologics.
	234 - ICH Q7: The GMP Framework for API Manufacturing	15 Apr 2026	00:13:55
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 in practice. Covers: • Scope and where GMP begins • API starting material (core concept) • GMP scaling across the process (Table 1) • Quality unit and QMS expectations • Production and in-process controls • Validation and change control • CMOs and supply chain • Clinical trial flexibility (Section 19) Timestamps 00:00 Intro 00:13 What Q7 Covers 01:23 Scope and GMP Start 02:19 API Starting Material 04:05 GMP Scaling (Table 1) 05:30 Quality and QMS 06:58 Production Controls 08:26 Validation 09:46 Change Control 10:27 CMOs / Supply Chain 12:11 Clinical 13:12 Takeaways https://database.ich.org/sites/default/files/Q7%20Guideline.pdf 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, and speaker with experience across companies including Pfizer, Gilead, and Baxter, supporting the development and launch of combination products across vaccines, biologics, and generics, including leading and supporting combination product transformations across large organizations.
	233 - Most Teams Misunderstand Specifications \| ICH Q6	08 Apr 2026	00:06:57
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 and controlling drug products and drug-device combination products. He breaks down how ICH Q6 formalizes: • what to test (attributes or CQAs tied to safety and efficacy) • how to test (methods and procedures) • what is acceptable (acceptance criteria or limits) All of which come together to support the release decision. He also covers the difference between ICH Q6A (small molecules) and ICH Q6B (biologics), highlighting the increased variability in biologics and the greater reliance on characterization and process understanding. Finally, he summarizes key themes from the 2024 ICH Q6(R1) concept paper, including: • alignment of shared principles across Q6A and Q6B • expanded scope to include new modalities and combination products • linkage to ICH Q12 lifecycle management and established conditions • a shift toward more science and risk based approaches with less reliance on routine batch testing ⸻ Key References • ICH Q6 Guidelines (Q6A and Q6B): https://www.ich.org/page/quality-guidelines • ICH Q6(R1) Concept Paper (2024): https://www.ich.org/page/quality-guidelines (navigate to Q6 revision concept paper) ⸻ Timestamps 00:00 Intro to ICH Q6 00:36 Host background 01:05 Why specifications matter 01:49 Q6A vs Q6B overview 02:33 Purpose of ICH Q6 02:59 What is a specification 04:27 Q6 R1 update themes 05:49 Lifecycle and risk based specifications 06:29 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, and regulatory expectations across drug and device domains.
	232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk	01 Apr 2026	00:34:14
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 this” or rely on a molder’s preferred grade, but those shortcuts can drive cost, delay timelines, and create downstream regulatory risk. Lucas breaks down a more structured, data-driven approach to material selection that balances performance, processability, regulatory compliance, cost, and sustainability. They cover how early material decisions impact total cost of goods, why late changes lead to retooling and delays, and how to think holistically across the device lifecycle. The conversation also explores common processing methods like injection molding and extrusion, key polymer categories, and emerging regulatory risks tied to additives, PFAS, and legacy materials. Subhi and Lucas discuss how GRAS and California Prop 65 are often misunderstood in medtech, and why biocompatibility is a device-level risk assessment, not a material checkbox grounded in screening, chemical characterization, and toxicological evaluation. ⏱️ Timestamps 00:00 Welcome and Guest Intro 00:43 Why Materials Drive Cost 02:17 Common Selection Pitfalls 03:35 Data-Driven Framework 06:10 Early Choices Prevent Rework 09:17 Processing Methods Overview 10:23 Polymer Categories Explained 12:58 Regulatory Risks and PFAS 19:26 GRAS and Prop 65 Basics 23:21 Biocompatibility Early Screening 28:55 ISO 10993 Updates 30:36 What Toxicologists Do 33:41 Where to Find Lucas 34:07 Closing Lucas Pianegonda Website: https://www.gradical.ch/ Lucas on LinkedIn: https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/ Lucas on YouTube: https://www.youtube.com/channel/UChPQB4eXQz3c_U2zZXAmEuQ ISO 10993 Overview: https://www.iso.org/standard/68936.html California Prop 65: https://www.p65warnings.ca.gov/ GRAS Overview (FDA): https://www.fda.gov/food/generally-recognized-safe-gras Lucas Pianegonda is a medical technology plastics expert and founder of Gradical, where he helps medtech companies make smarter material selection decisions. He specializes in a holistic approach that connects performance, manufacturability, regulatory risk, cost, and sustainability to prevent costly redesigns and delays later in development. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	231 - Audit Findings Explained: Nonconformity vs Observation (CQA)	25 Mar 2026	00:11:58
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-course I break down key terms like finding, nonconformity, observation, and noncompliance, and explains that everything must tie back to requirements and objective evidence. The episode covers when to write a nonconformity vs an observation, common severity levels (critical, major, minor), and how to structure clear findings. I also cover how to sequence audit results and where auditors often go wrong, especially when they insert opinion or recommend solutions. Timestamps 00:00 Course preview 00:42 Key audit terms 01:56 What makes findings reportable 04:16 Severity classification 06:42 Writing findings 07:57 Structuring reports 10:38 Auditor boundaries Subhi Saadeh is a certified ISO 13485 Lead Auditor, CQE, and CQA with experience leading audits and building quality systems across medical devices and combination products at companies like Baxter, Pfizer, and Gilead Sciences. Through Let’s ComBinate, he focuses on bridging the gap between pharma and devices through educational content, industry collaboration, and consulting.
	230 - How Pharma Misses Critical Market Signals with Joe Luminiello	23 Mar 2026	00:30:38
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 wrong. Joe introduces a practical framework built on three pillars: data (scientific publications and congresses), signal intelligence (press releases and filings), and human intelligence, which provides the context needed to interpret what those signals actually mean. While data and AI tools are becoming more accessible, Joe explains why interpretation and real-world insight remain the true differentiators in strategic decision-making. The conversation covers real-world applications across pharma strategy, including evaluating low-cost API suppliers, make-versus-buy decisions, competitor assessments, and forecasting. Subhi and Joe also discuss how cultural incentives and assumptions often shape forecasts more than data, and why even well-built models can miss significantly. Timestamps 00:00 Introduction 00:51 What is competitive intelligence 02:57 Human intelligence in practice 05:37 How insights are sourced 07:59 Validating and triangulating data 12:37 Forecasting and key assumptions 18:01 Common client blind spots 20:31 Speed of change in pharma 23:56 Why context matters more than raw data 27:27 Tools, congress strategy, and wrap-up Links RCG Intel: https://rcgintel.com/ Joseph Luminiello on LinkedIn: https://www.linkedin.com/in/joeluminiello/ Joseph Luminiello is the CEO and Co-Founder of RCG Intel, a boutique competitive intelligence consultancy serving the pharmaceutical and biotech sector. With more than 40 years of experience across healthcare, biopharma, and strategic intelligence, Joe has built his career around what he calls prescience, the ability to synthesize disparate data points and anticipate how they will shape the future. Before launching RCG Intel, Joe served as CEO of multiple biopharma companies, including AVM Biotechnology and Third Coast Therapeutics, where he raised capital and advanced drug development programs. As Founder and CEO of SmartHealth Catalyzer, he built a 150-member senior executive operations team and sourced over 130 intellectual property projects from Midwest universities. Earlier in his career, he spent six years at Takeda Pharmaceuticals, where he rose to Vice President of Business Development, contributed to diligence for Takeda’s acquisition of Nycomed, and helped launch Takeda Canada as its second employee. Subhi Saadeh is the Founder and Principal at Let’s ComBinate BioWorks. He is a Certified Quality Auditor and ISO 13485 Certified Lead Auditor with leadership experience at Baxter, Pfizer, and Gilead Sciences. Subhi has extensive experience across drug-device combination products, including supplier quality, development quality, design controls, purchasing controls, audits, and management of contract manufacturers and external partners. Through Let’s Combinate, he is focused on bridging the gap between pharma and devices by creating educational content, participating in industry groups, and providing consulting support to align development, quality, and regulatory expectations.
	229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products	11 Mar 2026	00:31:15
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 Q2 differs from validating functional and mechanical performance methods used for combination products. These methods often require an engineering mindset that incorporates measurement system analysis (MSA), gage R&R studies, and the use of fabricated surrogate standards when devices cannot be reused for testing. They also discuss platform test methods and how standards such as ISO 11040 and other ISO references can serve as starting points for method development. The conversation touches on the evolving alignment between ISO based device methods and pharmacopeial expectations such as USP <382>. The episode also covers make vs buy testing decisions, when to outsource specialized testing such as CCIT and extractables and leachables, and how sponsors manage oversight of contract testing laboratories. Timestamps 00:00 Welcome and Guest Introduction 00:53 ICH Q2 vs MSA Mindset Shift 04:37 Surrogate Standards for Mechanical Testing 11:12 Platform Methods and ISO 11040 15:14 ISO vs USP Verification Debate 20:06 Outsourcing Analytical Testing Strategy 24:07 Choosing the Right Test Lab 26:20 Sponsor Oversight of Contract Labs 30:09 Wrap Up About Jen Riter Jen Riter is an analytical testing and laboratory leader with nearly three decades of experience working in pharmaceutical packaging, drug delivery systems, and combination products. She has held leadership roles at West Pharmaceutical Services and Kindeva Drug Delivery, where her work has focused on analytical method development, validation, and testing strategies for drug delivery systems and injectable combination products. She is also a contributor to the Combination Products Handbook, where she authored a chapter on analytical testing and method validation for combination products. About Subhi Saadeh Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks, where he helps companies close the gaps between drug and device development, quality systems, and regulatory expectations. He is a Certified Quality Auditor and ISO 13485 Lead Auditor with leadership experience at Baxter, Pfizer, and Gilead Sciences including responsibility for management and oversight of assemble label pack sites and working with device primary, secondary and tertiary packaging suppliers. Subhi previously chaired the Combination Product Working Group for Rx-360, served as International Committee Chair for the Combination Products Coalition, and served on AAMI’s Combination Products Committee. He also hosts the Let’s Combinate podcast and is a writer and speaker on quality at the intersection of drugs and devices.
	228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently	04 Mar 2026	00:06:17
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 products cannot be fully characterized by physical and chemical testing alone and show inherent variability. It harmonizes expectations for viral safety, cell substrate controls including master and working cell banks, stability, and comparability after manufacturing changes. For combination products, Q5 mainly applies to the biologic drug constituent through stability and change impact rather than device requirements. 00:00 Intro to ICH Q5 00:25 Meet the Host 00:32 Why Biologics Need Q5 00:56 Key Risks Explained 02:11 What Q5 Covers 02:40 Scope and Structure 03:19 Q5 A to E Breakdown 04:19 How to Read Q5 05:05 Q5 for Combination Products 05:59 Wrap Up and Next Episode Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics	24 Feb 2026	00:28:05
Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements. Timestamps 00:00 Welcome and Guest Intro 00:53 The Hairiest CAPA Case 03:02 Human Error Root Cause 04:58 Common CAPA Misconceptions 06:11 Why Root Cause Fails 12:16 When to Open CAPA 17:26 CAPA Inputs and Triggers 19:28 One Process or Two 22:28 How to Investigate Properly 25:09 Tools for Root Cause 26:20 Problem Statement Basics 27:48 Wrap Up and Where to Find Georg Digel is the founder of Elevate CAPA and works with medical device quality leaders to make nonconformance and CAPA systems faster, stronger, and more audit-ready. He brings hands-on experience from early work on the production line through roles across consulting, startups, and larger organizations, with a focus on root cause and investigation quality. He also shares practical NC and CAPA breakdowns and training content with the MedTech community. LinkedIn: https://www.linkedin.com/in/georgdigel/ Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	226 - Navigating China NMPA Medical Device Requirements \| Standards, GMP Updates, Agents & Classification	18 Feb 2026	00:29:15
In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance under the NMPA. The conversation explores why Western companies often underestimate China’s regulatory expectations — particularly when assuming EU or U.S. approvals, ISO standards, or FDA clearances will translate directly. Elaine explains how China requires demonstration of safety and effectiveness against applicable local standards primarily GB (national standards) and YY (medical device industry standards) including both mandatory and recommended variants (e.g., GB vs GB/T, YY vs YY/T). The episode dives into China’s local type testing model and the role of Product Technical Requirements (PTRs) in defining test methods, parameters, accessories, and applicable standards for registration. Elaine also outlines how China’s quality system expectations align to China Medical Device GMP rather than ISO 13485 including major GMP updates taking effect in November 2026 and discusses implications for foreign manufacturers. Additional discussion topics include China agents and authorized representatives, clinical evaluation expectations, post-market reporting requirements, and how China’s device classification system can influence regulatory strategy. ⏱️ Timestamps 00:00 Welcome + Meet Elaine (MedTech Chopsticks) 00:38 Why China Is Different: Local Standards vs EU/US Assumptions 03:35 GB & YY Standards Explained (National vs Industry Standards) 05:07 Local Type Testing & PTRs: Building China Product Technical Requirements 06:52 China GMP Updates: Key Differences vs ISO 13485 12:42 China Agent vs EU Authorized Rep: Roles & Responsibilities 15:19 Choosing Local Test Labs: NMPA-Designated Testing Considerations 18:42 Planning Early: Standards Gaps, Clinical Evaluation & PMS Risks 24:43 China Certification & Device Classification Changes (Class I/II/III) 28:38 Where to Find Elaine + Closing Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions	11 Feb 2026	00:08:15
In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to solve, and how the ICH Q4 framework, Q4A, Q4B, and the Q4B annexes work together to determine when pharmacopeial test methods are considered interchangeable across ICH regions. The episode also explains the role of the Pharmacopoeial Discussion Group (PDG) in technical harmonization and walks through practical examples, including ICH Q4B Annex 3. ICH Guidelines (Quality): https://www.ich.org/page/quality-guidelines ICH Q4B Annex 3(R1) – Tests for Particulate Contamination (Subvisible Particles): https://database.ich.org/sites/default/files/Q4B%20Annex%203%28R1%29%20Guideline.pdf Timestamps 00:00 Introduction to the ICHQ Series 00:03 What Pharmacopeial Harmonization Means 00:42 Why ICH Q4 Exists 01:55 ICH Q4 Framework and Structure 02:54 Understanding Q4A, Q4B, and the Annexes 03:59 Practical Examples (Particulates, Disintegration) 08:05 Conclusion and Next Steps Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes	04 Feb 2026	00:09:27
In this episode of Let’s ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substances and drug products. Subhi explains what impurities are, why zero impurities is unrealistic in scalable manufacturing, and how ICH Q3 establishes a risk-based framework to protect patient safety and product quality. The episode walks through the structure of Q3A through Q3E, covering impurities formed during drug substance synthesis, degradation in drug products, residual solvents, elemental (metal) impurities, and extractables and leachables highlighting where drug delivery systems and combination products explicitly come into scope under Q3E. This episode is a high-level, practical overview focused on how to read ICH Q3, how the sections fit together, and where the guideline applies and stops across the drug product lifecycle. ⸻ Timestamps 00:00 Welcome to Let’s ComBinate 00:12 Introduction to ICH Q3 00:25 What Are Impurities and Why They Matter 00:51 Sources of Impurities and Risk-Based Control 02:11 Structure of ICH Q3 (Q3A–Q3E) 05:30 How to Read and Use ICH Q3 07:22 Q3E, Extractables & Leachables, and Drug Delivery Systems 09:21 Wrap-Up and Next Episode Preview Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	224 - ICH Q2 Explained: What Analytical Validation Really Requires	28 Jan 2026	00:10:43
In this episode of Let’s Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. The discussion covers key definitions, core validation characteristics, and how ICH Q2 applies to drug delivery systems and drug-device combination products. Subhi explains how the revised ICH Q2 guideline aligns with ICH Q14 and what that alignment means for harmonizing analytical validation expectations across regions and regulatory authorities. The episode walks through key validation characteristics including accuracy, precision, specificity, linearity, and range, and clarifies the relationship between ICH Q2 and ICH Q14. Practical guidance is also provided on how to read and apply ICH Q2 efficiently, particularly for teams working with combination products. Timestamps 00:00 Introduction to Let’s ComBinate 00:42 Purpose and importance of ICH Q2 03:11 Scope and product coverage 06:10 Key validation characteristics 08:15 Practical application and reading ICH Q2 10:23 Conclusion and next steps Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations	21 Jan 2026	00:09:39
In this episode of Let’s Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what has actually changed and what has stayed the same. ICH Q1 is the core stability guideline, and with the consolidation of multiple legacy guidelines into a single document, many readers have found the draft overwhelming. In this episode, Subhi steps back from line-by-line commentary and instead focuses on how to think about ICH Q1, how to read it efficiently, and how stability decisions are expected to be made. The discussion covers why stability was one of the first topics harmonized by ICH, the fundamental stability concepts that still anchor the guideline, and how the revised structure emphasizes lifecycle management and data evaluation rather than introducing new science. Subhi also explains how ICH Q1 applies to drug-device combination products, including the role of the device as part of the container-closure system and why in-use stability often matters more than long-term storage. This episode is part of an ongoing series walking through the ICH Q guidelines and is intended to help listeners navigate regulatory expectations with clarity and confidence. Timestamps 00:00 Introduction 00:36 What ICH Q1 Is and Why It Exists 02:59 Core Stability Concepts in ICH Q1 04:51 What’s Changing in the 2025 Draft 05:35 How to Read ICH Q1 07:16 ICH Q1 and Drug-Device Combination Products 09:09 Closing and What’s Next Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series	14 Jan 2026	00:12:13
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are organized and why that structure matters for drug and drug-device combination products. Subhi walks through the four main ICH guideline families, Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M), and explains how each fits into the broader product lifecycle. The episode places particular emphasis on the Quality guidelines, which form the backbone of pharmaceutical development, manufacturing control strategies, and lifecycle management. Rather than a deep dive into requirements, this episode is designed to orient listeners to the full ICH landscape. It helps teams understand where different guidelines apply, who typically owns them, and how they collectively shape regulatory expectations. Future episodes in the series will explore individual Quality guidelines in detail. In this episode, you will learn What an ICH guideline is and how it differs from regulations and standards Why guidelines still matter during inspections and enforcement How ICH organizes its guidance into Q, S, E, and M categories A high-level overview of the Quality Guidelines (Q1 through Q14), including: Stability (Q1) Analytical validation and development (Q2 and Q14) Impurities (Q3) Quality by Design and risk management (Q8 and Q9) Pharmaceutical Quality Systems and lifecycle management (Q10 through Q12) Continuous manufacturing (Q13) How different functional teams interact with different parts of the ICH framework The next episode begins the deep dive into the Quality Guidelines, starting with ICH Q1 on Stability. Timestamps 00:00 Introduction to the Series 00:48 Overview of ICH Guidelines 01:36 What an ICH Guideline Is and Is Not 03:04 The Four ICH Guideline Categories 04:08 Quality Guidelines Overview 08:46 Safety Guidelines Overview 09:28 Efficacy Guidelines Overview 10:33 Multidisciplinary Guidelines Overview 11:28 Wrap-Up and Next Steps Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	221 - What Is ICH and Why It Matters	07 Jan 2026	00:14:30
In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH) and its impact on drug and drug–device combination products.Subhi introduces what ICH is, why it was created, and how its guidelines shape global expectations for pharmaceutical quality, safety, efficacy, and lifecycle management. He walks through the historical challenges that existed before harmonization, explains how ICH guidelines are developed through the five-step process, and outlines why these standards matter—especially for teams working at the intersection of drugs and devices.The episode also sets the roadmap for the series, including upcoming deep dives into the ICH Quality guidelines (Q1–Q14) and how they apply in practice to combination products.00:00 Welcome to Let’s Combinate00:37 Why ICH Matters for Drug–Device Products02:22 What Is ICH?05:21 Evolution of ICH Guidelines10:18 The Five-Step ICH Guideline Process11:38 How This Series Will Work14:09 Wrap-Up and What’s NextSubhi Saadeh is a Quality Professional, Founder of Let's Combinate BioWorks and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	220 - Managing Oneself, Reflections and a New Series on ICH	31 Dec 2025	00:08:29
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com 🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this end of year episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh reflects on the past year through the lens of Managing Oneself by Peter Drucker. Using the book’s core questions around strengths, values, learning style, performance, and contribution, Subhi shares how his thinking has evolved and how those ideas continue to shape his approach to work and learning. The episode explores the idea of learning by teaching and why podcasting has become an important way for Subhi to deepen his own understanding of complex topics. He also shares a brief life and professional update, including the launch of Let’s ComBinate BioWorks and a shift in focus toward work that bridges the drug and device worlds. The conversation closes with reflections on Drucker’s ideas about the second half of a career and introduces a new upcoming podcast series focused on ICH guidelines. Subhi outlines how the series will take a high level, practical approach to ICH, emphasizing how to read and engage with the guidance rather than treating it as a checklist. Episode Timeline 00:00 Introduction and episode overview 00:31 Introducing the upcoming ICH series 01:36 Reflections on Managing Oneself 03:27 Life and professional updates 06:59 Thinking about the second half of a career 08:19 Closing thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness	24 Dec 2025	00:25:30
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what’s changing in FDA pre-approval and pre-license inspections—and why the “inspection side” of approval is becoming a bigger conversation. They cover how PAIs and PLIs fit into the approval pathway, why Complete Response Letters (CRLs) can be driven by inspection outcomes, and what it would mean to “decouple” approval decisions from inspection timing. The conversation also explores the pros and cons of unannounced inspections, the realities of FDA capacity and scheduling, and how FDA’s PreCheck program is shaping the onshoring/manufacturing-readiness narrative in the U.S. Finally, they zoom out to compare international inspection approaches and what global trends could signal for industry. What you’ll learn -The difference between Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs) -How inspection outcomes can lead to CRLs—even when the application looks strong on paper -Why industry is talking about decoupling approval from PAI timing -The idea behind FDA PreCheck and what “facility readiness” looks like -Unannounced inspections: where they help, where they create risk -How inspection expectations compare across global regulators Chapters 00:00 Introduction and Guest Welcome 00:10 Understanding Pre-Approval and Pre-License Inspections 01:54 Challenges and Industry Perspectives 03:08 FDA Complete Response Letters (CRLs) 05:23 Unannounced Inspections: Pros and Cons 08:55 Economic and Regulatory Considerations 12:37 Onshoring and the PreCheck Program 22:51 Global Regulatory Landscape 25:11 Conclusion and Farewell Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)	17 Dec 2025	00:09:10
In this short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means. He compares batch vs. continuous, explains how a batch still exists in continuous manufacturing, and covers the essentials quality teams care about: RTD/traceability, control strategy, and disturbances/diversion plus a quick high-level note on validation, release, and lifecycle. Timestamps 00:00 Intro 01:00 Batch vs. continuous (and batch definition) 03:00 Modes of continuous manufacturing (ICH Q13 examples) 04:30 RTD & traceability 06:00 Control strategy 07:30 Disturbances & diversion 09:00 Validation / release / lifecycle (high level) 10:00 Wrap-up Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and host of the Let’s Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE. For questions, inquiries, or suggestions, please reach out at letscombinate.com or on the show’s LinkedIn Page.
	217 - 5 Fixable Problems Holding Back Drug–Device Programs	10 Dec 2025	00:17:30
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space. This episode provides practical insights and strategies for overcoming these common hurdles to enhance quality and efficiency in developing combination products. 00:00 Introduction and Host Background 00:43 Overview of Development Processes 01:51 Issue 1: Documentation Approach in Design Transfer 04:45 Issue 2: Early Input from Manufacturing and Assembly SMEs 07:26 Issue 3: Control Strategies and Sampling Plans 10:23 Issue 4: Method Transfer and Control Planning 12:02 Issue 5: Qualification of Supplied Components 14:47 Issue 6: Monitoring Expectations in Combination Products 16:55 Conclusion and Summary Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and host of the Let’s Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke	03 Dec 2025	00:21:51
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. They discuss: - The hidden costs of regulatory failure and how to avoid them - Why early engagement with regulatory agencies is critical - Global regulatory models, including emerging markets like China and the UAE - A clear explanation of UDI and serialization - How regulatory impacts extend beyond compliance teams - The role of LinkedIn and storytelling in regulatory careers - Steven’s experience running for the European Parliament and what it taught him about policy Timestamps 00:00 – Introduction and Guest Welcome 00:38 – The Hidden Costs of Regulatory Failure 03:47 – Engaging with Regulators Early 05:26 – Global Regulatory Models and Emerging Markets 10:07 – Understanding UDI and Serialization 15:16 – The Power of LinkedIn and Personal Stories 17:11 – Running for European Parliament and Policy Insights 21:18 – Conclusion and Contact Information Connect with Steven O’Rourke Website: https://clarifi.fi LinkedIn: https://linkedin.com/in/sorourkde Subscribe to Let’s Combinate for more conversations exploring combination product development, quality systems, and regulatory strategy. Stephen O’Rourke is a regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food startups navigate EU and US regulatory pathways. Based in Helsinki, Finland, his work spans UDI, 510(k), EU MDR, combination products, and novel ingredient safety. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	215 - Why Aren’t Technical People Leading Drug-Device Audits?	26 Nov 2025	00:13:59
In this episode of Let’s Combinate, Subhi Saadeh breaks down why more engineers in pharma, medical devices, and combination products should seriously consider becoming auditors. Sparked by a question at a PDA conference: “Why don’t more technical people lead audits?” This episode explores the gap between technical expertise and true audit competency. Subhi explains how engineers who combine their technical background with audit training often become the most effective auditors. They gain a system-level perspective, understand how design decisions ripple through the QMS, and can identify systemic root causes that others overlook. He also clears up common misconceptions about auditing, including the idea that it’s just paperwork or checklist work, and reframes it as one of the fastest ways to build regulatory fluency, strengthen quality systems understanding, and expand career versatility across industries. The episode closes with practical steps for how engineers can get started: shadowing internal audits, learning audit frameworks and methodologies, taking formal training, and seeking mentorship from experienced auditors. Timestamps: 00:00 – Why Engineers Should Consider Auditing 01:10 – How Auditing Expands Technical Perspective 05:26 – Misconceptions & Why Engineers Avoid Auditing 11:25 – How to Start Your Audit Journey 13:27 – Final Thoughts: Seeing the System, Not Just the Spec Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and the host of Let’s Combinate: Drugs + Devices. With a background spanning Quality, Manufacturing Operations, and R&D, he has supported the development and launch of hardware devices, disposable systems, and drug–device combination products across vaccines, generics, and biologics at some of the industry’s largest medical device and pharma organizations. Subhi currently serves as the Working Group Chair for the Rx-360 Combination Products Working Group and previously served as the International Working Group Chair for the Combination Products Coalition (CPC). He has also contributed to ASTM Committee E55 and AAMI’s Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)	19 Nov 2025	00:19:15
In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transformative journey involving CQE certification and how it boosted his confidence and expertise in quality engineering. They explore the practical applications of Design of Experiments (DOE), including a real-life example where Andy applied DOE concepts at work. Andy also discusses the value of various ASQ certifications, including CQE, CQA, CQM/OE and Six Sigma Green Belt, emphasizing their importance for career growth. The conversation extends to non-ASQ certifications such as PMP, highlighting their relevance for leadership roles. By comparing practices from various industries, including automotive and medical devices, they underscore the importance of cross-industry learning. Andy concludes by inviting listeners to join his courses to further their own professional development. 00:00 Welcome and Introduction 00:48 The Impact of CQE Certification 02:23 Applying DOE in Quality Engineering 05:42 Top ASQ Certifications 13:35 Non-ASQ Certifications and Leadership 15:55 Cross-Industry Learnings 18:45 Conclusion and Contact Information Andy Robertson is the founder of CQE Academy and a leading educator in the quality profession. With a background in medical devices and years of hands-on experience as a quality engineer, he built a global audience through his practical, passionate approach to teaching CQE, Green Belt, and quality systems fundamentals. Andy’s work centers on helping professionals gain confidence, accelerate their careers, and master the core tools of quality through clear, accessible education. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
	213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site	12 Nov 2025	00:43:30
What happens when you go all in on a generic injectable that no one else wants, and it turns into a one hundred million dollar product in the first year? In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Usman Ahmad, former CEO of Nexus Pharmaceuticals and now CEO of Quetzal Therapeutics. Together they trace his journey from corporate finance to building a generics powerhouse with his parents, scaling a sterile injectable facility, and ultimately selling it to Eli Lilly for just under one billion dollars. They discuss the philosophy of finding the "right to win," what most companies miss about manufacturing capacity and equipment selection, how to build a team with deep industry know-how, and why Usman is now focused on bringing therapies to patients with rare diseases. This is a practical, personal, and strategic look at building something from the ground up, deciding not to sell too early, and learning how to do the hard things with intention. Topics include: -How to select the right generic molecules beyond patent expiry -Early success with isoproterenol and API sourcing -Why Nexus turned down acquisition offers -Building a commercial salesforce from scratch -Designing a facility with high speed prefilled syringe and lyo capacity -Why most other sterile sites failed -The billion dollar sale to Lilly -Launching Quetzal and developing oral arsenic for APL -The brain-eating amoeba drug and ultra rare disease strategy -Faith, confidence, and decision making under pressure Timestamps: 00:00 Introduction and Guest Welcome 00:24 From Wall Street Finance to Pharma 01:42 How Usman Selected Winning Generics 02:58 Early Challenges Building a Generics Company 05:29 Family R&D Expertise and Business Dynamics 11:44 First Generic Launch and Commercial Impact 16:28 Building Sterile Injectable Manufacturing Capacity 18:16 Sterile Facility and Equipment Strategy 22:40 Prefilled Syringe and Vial Line Capabilities 23:07 Big Pharma Interest and Selling the Facility 26:02 Nexus Pharma Services and the Lilly Deal 27:23 Post‑Sale Reflections and New Ventures 28:30 Launching Quetzal Therapeutics and Rare Disease Focus 33:30 New Challenges and Confidence in Drug Development 39:55 Importance of People, Teams, and Relationships 41:40 Books That Shaped Usman’s Thinking 42:29 Where to Connect with Usman Learn more: https://quetzaltx.com Connect with Usman: https://www.linkedin.com/in/usman-ahmed-a351b928 More episodes: https://letscombinate.com Usman Ahmad is the Founder and CEO of Quetzal Therapeutics, and former CEO of Nexus Pharmaceuticals, where he led the company through explosive growth and the billion-dollar sale of its manufacturing facility to Eli Lilly. With a background in finance and a deep passion for healthcare innovation, Usman now focuses on bringing treatments to patients with rare and underserved diseases. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

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