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

    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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Apr 22

    235 - ICH Q8: How Pharmaceutical Development Actually Works

    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.

    11 min

  7. Apr 15

    234 - ICH Q7: The GMP Framework for API Manufacturing

    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.

    14 min

  8. Apr 8

    233 - Most Teams Misunderstand Specifications | ICH Q6

    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.

    7 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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