Podcast
Let's Combinate - Drugs + Devices
Hosted by Subhi Saadeh · EN
Hello Combi-Nation!
Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on.
My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers.
Whether you're background is Pharma, Device or both, I invite you to listen and together we can simplify by Combinating!
31episodes
Episodes
Newest firstAll episodes
239 - ICH Q11 in 6 Minutes
2w ago00:06:06Tap to summarizeIn 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.Timestamps00:00 ICH Q11 overview00:47 Drug substance basics01:14 Where Q11 fits in the ICH Quality framework02:15 Section 3: Manufacturing process development03:26 Linking drug substance quality to drug product quality04:25 Section 5: Starting materials05:41 Section 6: Control strategy06:11 Wrap-up and next episodeSubhi 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.
Transcribe →238 - 6 Audit Strategies Every Auditor Should Know
3w ago00:10:04Tap to summarizeSix Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and DiscoveryCourse Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseIn 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.Timestamps00:00 Six Audit Strategies Overview00:22 Why Strategy Matters01:13 Course Context and Setup02:28 Tracing Method Explained03:26 Process Approach Walkthrough04:21 Department Method Deep Dive05:26 Element Method Against Standards06:12 Discovery Method String Pull06:36 Pros, Cons, and Final Summary09:53 Wrap Up and Next SessionSubhi 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.
Transcribe →237 - ICH Q10: The Pharmaceutical Quality System
4w ago00:08:12Tap to summarizehis 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 Setup00:14 Why ICH Q10 Matters01:21 Lifecycle and Phase-Appropriate GMP02:23 GMP Foundation and the PQS Model02:58 Management Responsibility03:31 Core PQS Elements04:26 Enablers: Knowledge Management and QRM04:40 Guideline Walkthrough: Sections 1 to 306:37 Continual Improvement of the PQS07:45 Wrap Up and Next EpisodeSubhi 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.
Transcribe →236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences
Apr 2900:12:16Tap to summarizeICH 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 riskKey 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 Q900:48 What is Risk in ICH Q901:44 Scope and Core Principles03:21 Initiating QRM05:09 Risk Assessment (Hazards, Likelihood, Severity)07:27 Risk Control (Reduction and Acceptance)08:46 Risk Communication and Review10:04 ICH Q9 vs ISO 1497111:51 Wrap UpICH Q9(R1) Final Guideline: https://database.ich.org/sites/default/files/ICH_Q9-R1_Guideline_Step4_2023_0118.pdfICH Q9 Briefing Pack: https://ich.org/page/q9r1-briefing-packSubhi 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.
Transcribe →235 - ICH Q8: How Pharmaceutical Development Actually Works
Apr 2200:10:49Tap to summarizeThis 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=orlPpfQvb5kQBD vs. Design Controls: https://www.youtube.com/watch?v=W_LSD0kKQ3400:00 Introduction to ICH Q800:42 Related QbD Videos01:12 Structure of ICH Q802:28 Objective and Scope04:49 Annexes and QbD Concepts05:20 Quality Target Product Profile06:33 Critical Quality Attributes07:09 Design Space and DoE09:17 Control Strategy10:06 Submission and Wrap-UpSubhi 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.
Transcribe →234 - ICH Q7: The GMP Framework for API Manufacturing
Apr 1500:13:55Tap to summarizeIn 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)Timestamps00:00 Intro00:13 What Q7 Covers01:23 Scope and GMP Start02:19 API Starting Material04:05 GMP Scaling (Table 1)05:30 Quality and QMS06:58 Production Controls08:26 Validation09:46 Change Control10:27 CMOs / Supply Chain12:11 Clinical13:12 Takeawayshttps://database.ich.org/sites/default/files/Q7%20Guideline.pdfSubhi Saadeh is the Founder and Principal at Let’s ComBinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across 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.
Transcribe →233 - Most Teams Misunderstand Specifications | ICH Q6
Apr 800:06:57Tap to summarizeICH 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)⸻Timestamps00:00 Intro to ICH Q600:36 Host background01:05 Why specifications matter01:49 Q6A vs Q6B overview02:33 Purpose of ICH Q602:59 What is a specification04:27 Q6 R1 update themes05:49 Lifecycle and risk based specifications06:29 Wrap up and next stepsSubhi Saadeh is the Founder and Principal at Let’s Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains.
Transcribe →232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk
Apr 100:34:14Tap to summarizeSubhi 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 Intro00:43 Why Materials Drive Cost02:17 Common Selection Pitfalls03:35 Data-Driven Framework06:10 Early Choices Prevent Rework09:17 Processing Methods Overview10:23 Polymer Categories Explained12:58 Regulatory Risks and PFAS19:26 GRAS and Prop 65 Basics23:21 Biocompatibility Early Screening28:55 ISO 10993 Updates30:36 What Toxicologists Do33:41 Where to Find Lucas34:07 ClosingLucas 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_U2zZXAmEuQISO 10993 Overview: https://www.iso.org/standard/68936.htmlCalifornia Prop 65: https://www.p65warnings.ca.gov/GRAS Overview (FDA): https://www.fda.gov/food/generally-recognized-safe-grasLucas 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.
Transcribe →231 - Audit Findings Explained: Nonconformity vs Observation (CQA)
Mar 2500:11:58Tap to summarizeThis 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-courseI 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.Timestamps00:00 Course preview00:42 Key audit terms01:56 What makes findings reportable04:16 Severity classification06:42 Writing findings07:57 Structuring reports10:38 Auditor boundariesSubhi 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.
Transcribe →230 - How Pharma Misses Critical Market Signals with Joe Luminiello
Mar 2300:30:38Tap to summarizeIn 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.Timestamps00:00 Introduction00:51 What is competitive intelligence02:57 Human intelligence in practice05:37 How insights are sourced07:59 Validating and triangulating data12:37 Forecasting and key assumptions18:01 Common client blind spots20:31 Speed of change in pharma23:56 Why context matters more than raw data27:27 Tools, congress strategy, and wrap-upLinksRCG 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.
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