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

Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and Discovery   Course Link: https://cqeacademy.teachable.com/p/the-cqa-master-class-course   In this episode, Subhi explains why selecting the right auditing strategy matters when

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

This is a lesson out of my ASQ CQA course with Andy Robertson, on how to write and classify audit findings. Resources Access the full CQA course here I break

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

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 validation under

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