Let's Combinate - Pharma + Medical Devices with Subhi Saadeh

Subhi Saadeh
  • 5.0 (4)
  • Life Sciences

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

  1. 5d ago

    259 - The Career Lesson I Learned the Hard Way in Pharma

    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.

  2. Oct 12

    258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin

    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

  3. Oct 5

    257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products

    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

  4. Sep 28

    256 - The New FDA Inspection Playbook: Where to Start with QMSR

    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

  5. Sep 21

    255 - Audit Interview Techniques: How Good Auditors Get Better Evidence

    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

  6. Sep 13

    254 - Saying No Is the Easy Part of Quality

    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

  7. Sep 7

    253 - FDA Is Making Big Changes to Its Inspection Approach

    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 Introduction00:48 FDA’s generalist and specialist inspection models03:52 What is Bioresearch Monitoring (BIMO)?05:03 What makes someone an effective FDA investigator?08:39 Technical expertise versus auditing and inspection skills11:25 What FDA investigators are actually looking for14:07 Eric’s experience conducting 800–1,000 inspections15:11 How investigators prepare, inspect, and write reports19:44 Why FDA investigators sometimes “phone home”23:35 The transition from ORA to OII28:00 What responsibilities remain within OII?30:31 FDA inspections versus investigations33:05 The IOM, QSIT, and investigator discretion38:25 How industry should use FDA compliance programs44:13 What companies waste time preparing for45:55 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-fdaProject 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/@LetsCombinateWebsite: https://letscombinate.com

  8. Aug 31

    252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)

    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

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

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