Podcast Episodes
Back to SearchQA Mistakes That Keep Weak Quality Systems Alive
Many of the most common mistakes in Quality Assurance are not caused by a lack of technical knowledge. They result from how organizations think about…
5 months, 3 weeks ago
Risk Management in Pharma: Lessons from Artemis II
The Artemis II mission offers a powerful analogy for how pharmaceutical organizations should approach readiness, risk management, and system reliabil…
5 months, 3 weeks ago
The LISTEN Model: Better Thinking for Pharma QA
Strong Quality Assurance professionals do more than make decisions — they listen.
In this episode of The GMP Insider, we introduce the LISTEN Model, …
6 months ago
"Retraining" Is the Most Overused CAPA in Pharma — Here's Why
Retraining is one of the most common corrective actions used in pharmaceutical investigations — but it is often applied even when the true issue is n…
6 months ago
Why People Stay Silent in Weak Quality Cultures
One of the clearest indicators of a weak quality culture is when employees hesitate to report problems.
In strong organizations, people raise deviati…
6 months, 2 weeks ago
"We've Always Done It This Way": Pharma's Most Dangerous Phrase
“We've always done it this way” is one of the most dangerous mindsets in pharmaceutical quality systems.
As processes evolve, regulations change, and…
6 months, 2 weeks ago
Activity vs Effectiveness: What FDA Really Wants to See
In Quality Assurance, activity is often mistaken for effectiveness. CAPAs are closed, training is completed, and SOPs are revised — but the underlyin…
6 months, 2 weeks ago
"Human Error" Is Not a Root Cause: QA Investigation Mistake
“Human error” is one of the most common conclusions in pharmaceutical quality investigations — but it is rarely the true root cause.
In this episode …
6 months, 2 weeks ago
How FDA Inspects Biologics: Risk-Based GMP Explained
Episode 22
Biological drug products present unique manufacturing and quality challenges due to their complexity, aseptic processing requirements, and critical p…
6 months, 2 weeks ago
AI Meets FDA: Why Credibility Beats Capability in Pharma
Episode 21
Artificial Intelligence is becoming increasingly important across the pharmaceutical industry, influencing clinical trials, manufacturing, pharmacovi…
6 months, 2 weeks ago