Let's Combinate - Drugs + Devices

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 Huhti 10min

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 Huhti 13min

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 Huhti 6min

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 Huhti 34min

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 Maalis 11min

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 Maalis 30min

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 Maalis 31min

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 Maalis 6min