Let’s Combinate · Drugs + Devices
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Drugs, devices, and combination products. Practical perspectives from Subhi Saadeh and guests across the industry.
Latest 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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