003 - “Standard Understanding” with Mark Swanson

In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled.He places Q11 in context with...

20 Maj 6min

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and DiscoveryCourse Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-courseIn this episode,...

13 Maj 10min

his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style...

6 Maj 8min

ICH Q9 is one of the most referenced guidelines in pharma and one of the most misunderstood.In this video, I break down what Quality Risk Management (QRM) actually is, how the process works, and how i...

29 Apr 12min

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

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

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

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