Consulting & training
Combinate 
BioWorks
Combination product quality, audits, and clinical readiness.
Explore Our ServicesBuilt around
combination products.
Combination product consulting, quality systems, audits, and training through BioWorks. Industry conversations and technical content through Let’s Combinate and Studios.
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Subhi SaadehFounder · Combination Product Expert & Quality Strategist
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TheCombinate
Model
Three ways to work together.
Combinate
Podcast
Let’s Combinate
Conversations that connect drugs, devices, and the people behind them.
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Technical media
Combinate 
Studios
Subhi Saadeh and a professional production team make your expertise clear through video.
Explore Studios
Meet the founder
Hi, I’m Subhi.
Subhi Saadeh
Combination Product Expert
& Quality Strategist
I help teams solve combination product quality challenges, drawing on engineering and quality roles at Baxter, Pfizer, and Gilead. Through Combinate, I bring that experience to consulting, education, and industry conversations.
More about SubhiLatest from Let’s Combinate.
The New FDA Inspection Playbook: Where to Start with QMSR
Audit Interview Techniques: How Good Auditors Get Better Evidence
Quality Assurance Leadership: How to Make Tough Quality Decisions in Pharma & MedTech
Audit Agenda: Your Grocery List
Address Quality Issues before FDA Arrives
FDA Inspection Readiness: What Companies Waste Time Preparing For
What Is AQL? Acceptance Sampling, Attributes vs. Variables & OC Curves
The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy
I’m Changing the Channel
PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?
The Best Audit Advice Nobody Told Me
What Is a Quality Unit? QA vs. QC Explained
Why All Pharma & MedTech Professionals Should Work in Quality
The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)
Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector
Do You Know The 5 Differences Between Drugs & Devices?
Why Kitting an APPROVED Medical Device with a Drug Create So Much Work
Most Auditors Only Use One Audit Strategy
Wait… We’ve Been Validating Methods Backwards? | ICH Q14 Explained
ICH Q13: Continuous Manufacturing, Batches, Residence Time Distribution and Control Strategy
ICH Q12: What’s Binding? Established Conditions and Post-Approval Change
ICH Q11 Explained: Drug Substance & API in 6 Minutes
6 Audit Strategies Every Auditor Should Know
ICH Q10: The Pharmaceutical Quality System
ICH Q9 Explained: Quality Risk Management (QRM) + ISO 14971 Differences
ICH Q8: How Pharmaceutical Development Actually Works
ICH Q7: The GMP Framework for API Manufacturing
ICH Q6: Quality Control Starts with Specifications
MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk
Audit Findings Explained: Nonconformity vs Observation (CQA)
How Pharma Misses Critical Market Signals
Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently
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Videos 1–3 of 33
Courses & professional education
The CQA Master Class.
Prepare for the Certified Quality Auditor exam with structured study and practical auditing concepts.
Subhi Saadeh, CQA
Course instructor and co-creator with Andy Robertson at CQE Academy.
- Self-paced lessons
- Practice questions
- Exam Day Guide
Course details and enrollment through CQE Academy.
