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 Maalis 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 Maalis 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 Maalis 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 Maalis 6min
227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics
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.Times...
24 Helmi 28min
226 - Navigating China NMPA Medical Device Requirements | Standards, GMP Updates, Agents & Classification
In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance un...
18 Helmi 29min
226 - ICH Q4 Explained: How Pharmacopeial Methods Are Accepted Across Regions
In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to solve, and how the ICH Q4 fr...
11 Helmi 8min
225 - ICH Q3A, Q3B, Q3C, Q3D and Q3E - EXPLAINED in 10 Minutes
In this episode of Let’s ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in drug substan...
4 Helmi 9min
