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187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)
Manage episode 481153894 series 3325357
What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?
In this episode of Let’s Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design.
Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building safe, effective, and compliant combination products.
Whether you work in drug development, medical devices, or the space in between, this episode will help you:
-Understand the regulatory foundations of QbD (ICH Q8) and design controls (FDA 21 CFR 820.30)
-Learn the core tools and deliverables (like CQAs, QTPP, design verification & validation, and risk assessments)
-See how each system addresses user needs, therapeutic effects, and process control
-Apply both systems effectively in combination product developmentTimestamps:
00:00 – Intro: Why Compare QbD and Design Controls?
01:31 – Philosophical Differences: Process vs. Product Control
03:10 – Practical Examples: Drugs vs. Devices
05:13 – Origins and Frameworks: ICH Q8 and Design Controls Regulation
06:46 – Deep Dive: What Are Design Controls? (Inputs, Outputs, DHF, V&V, Transfer)
11:51 – What Is Quality by Design (QbD)? (QTPP, CQAs, Design Space, DOE)
15:39 – Final Takeaways: How to Use Both in Combination Products
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.
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ICH Q8, Q9, Q10, and Q12ISO 14971 Risk ManagementDifferences between usability engineering and clinical trialsThe role of control strategies and process monitoring in pharmaRelevant for:Regulatory affairs professionalsQuality engineers in pharma and medtechDrug/device development teamsAnyone preparing for combination product submissions or audits
191 episodes
Manage episode 481153894 series 3325357
What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?
In this episode of Let’s Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design.
Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building safe, effective, and compliant combination products.
Whether you work in drug development, medical devices, or the space in between, this episode will help you:
-Understand the regulatory foundations of QbD (ICH Q8) and design controls (FDA 21 CFR 820.30)
-Learn the core tools and deliverables (like CQAs, QTPP, design verification & validation, and risk assessments)
-See how each system addresses user needs, therapeutic effects, and process control
-Apply both systems effectively in combination product developmentTimestamps:
00:00 – Intro: Why Compare QbD and Design Controls?
01:31 – Philosophical Differences: Process vs. Product Control
03:10 – Practical Examples: Drugs vs. Devices
05:13 – Origins and Frameworks: ICH Q8 and Design Controls Regulation
06:46 – Deep Dive: What Are Design Controls? (Inputs, Outputs, DHF, V&V, Transfer)
11:51 – What Is Quality by Design (QbD)? (QTPP, CQAs, Design Space, DOE)
15:39 – Final Takeaways: How to Use Both in Combination Products
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.
------------------------
ICH Q8, Q9, Q10, and Q12ISO 14971 Risk ManagementDifferences between usability engineering and clinical trialsThe role of control strategies and process monitoring in pharmaRelevant for:Regulatory affairs professionalsQuality engineers in pharma and medtechDrug/device development teamsAnyone preparing for combination product submissions or audits
191 episodes
All episodes
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1 188 – Certified Quality Auditor(CQA) and Audits in the Future 15:39

1 187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained) 16:26

1 186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech 12:38

1 185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder 25:51

1 184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained 30:37

1 183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products 37:11

1 182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma 18:42

1 181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry? 20:14

1 180 - MIT Leadership Expert Reveals Management Secrets for Scientists! 25:18

1 179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing 9:27

1 178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know 31:22

1 177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED 10:58

1 176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski 26:20

1 175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau 39:49

1 174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin 23:57
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