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PODCAST

Let"s Combinate - Drugs + Devices with Subhi Saadeh

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

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All Episodes

00:06:06

239 - ICH Q11 in 6 Minutes

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/05/20

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

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00:10:04

238 - 6 Audit Strategies Every Auditor Should Know

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/05/13

Six 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

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00:08:12

237 - ICH Q10: The Pharmaceutical Quality System

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/05/06

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

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00:12:16

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

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/04/29

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 riskKey differences vs ISO 14971

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00:10:49

235 - ICH Q8: How Pharmaceutical Development Actually...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/04/22

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

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00:13:55

234 - ICH Q7: The GMP Framework for API Manufacturing

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/04/15

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

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00:06:57

233 - Most Teams Misunderstand Specifications | ICH Q6

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/04/08

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

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00:34:14

232 - MedTech Material Selection: Cost, Compliance,...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/04/01

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,

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00:11:58

231 - Audit Findings Explained: Nonconformity vs...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/03/25

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-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

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00:30:38

230 - How Pharma Misses Critical Market Signals with...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/03/23

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

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00:31:15

229 -Outsourcing Analytical Testing: What Sponsors...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/03/11

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

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00:06:17

228 - ICH Q5 EXPLAINED: Why Regulators Treat...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/03/04

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

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00:28:05

227 - When Should You Open a CAPA? Triggers, Human...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/02/24

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.Timestamps00:00 Welcome and Guest Intro00:53 The Hairiest CAPA Case03:02 Human Error Root Cause04:58 Common CAPA Misconceptions06:11 Why Root Cause Fails12:16 When to Open CAPA17:26 CAPA Inputs and Triggers19:28 One Process or Two22:28 How to Investigate Properly25:09 Tools for Root Cause26:20 Problem

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00:29:15

226 - Navigating China NMPA Medical Device...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/02/18

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

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00:08:15

226 - ICH Q4 Explained: How Pharmacopeial Methods Are...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/02/11

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

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00:09:27

225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/02/04

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

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00:10:43

224 - ICH Q2 Explained: What Analytical Validation...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/01/28

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

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00:09:39

223 - What’s Changing in ICH Q1 and What Isn’t:...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/01/21

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

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00:12:13

222 - How ICH Guidelines Are Organized: Understanding...

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/01/14

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

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00:14:30

221 - What Is ICH and Why It Matters

Let"s Combinate - Drugs + Devices with Subhi Saadeh ·

2026/01/07

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

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