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 “we’ve always used this”...

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-course I break down key term...

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 most companies get it wrong....

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 ICH Q2 d...

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 living systems where produc...

Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better problem statements. Timestamps 00:00 Welcome and ...