Let's Combinate - Drugs + Devices

Subhi Saadeh
  • 4.9 (14)
  • Life Sciences
  • Updated Weekly

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. 3d ago

    242 - Pharma/MedTech Audits: 6 Strategies for Choosing Where to Start

    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

    12 min

  2. Jun 10

    241 - ICH Q14 Explained: Have We Been Validating Methods Backwards?

    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

    10 min

  3. Jun 3

    240 - ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy

    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.

    11 min

  4. May 27

    239 - ICH Q12: What’s Binding? Established Conditions and Post-Approval Changes

    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 approvalHow ICH Q12 supports more predictable lifecycle managementReporting categories for post-approval CMC changesEstablished Conditions versus supporting informationExamples of EC candidates, including CQAs, CPPs, material attributes, methods, sites, and process informationWhy overcommitting or undercommitting ECs creates lifecycle riskHow PACMPs help companies plan future changesWhat belongs in the PLCM documentHow ICH Q12 applies to drug-device combination productsWhy a strong PQS is essential for making Q12 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.

    11 min

  5. May 20

    239 - ICH Q11 in 6 Minutes

    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.

    6 min

  6. May 13

    238 - 6 Audit Strategies Every Auditor Should Know

    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.

    10 min

  7. May 6

    237 - ICH Q10: The Pharmaceutical Quality System

    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.

    8 min

  8. Apr 29

    236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

    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.

    12 min
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Ratings & Reviews

4.9
out of 5
14 Ratings

About

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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