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...
22 Apr 10min
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 ...
15 Apr 13min
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 ce...
8 Apr 6min
232 - MedTech Material Selection: Cost, Compliance, Sustainability, and Biocompatibility Risk
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...
1 Apr 34min
231 - Audit Findings Explained: Nonconformity vs Observation (CQA)
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-cour...
25 Mar 11min
230 - How Pharma Misses Critical Market Signals with Joe Luminiello
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 mos...
23 Mar 30min
229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products
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 ...
11 Mar 31min
228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently
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 li...
4 Mar 6min
