You can't change culture without changing people's behavior first.

This podcast explores aspects of GCP and PV relevant to QPs and quality professionals. We cover what is different when releasing IMPs, what to be aware of beyond GMP, how to ensure product technical complaints link with safety reporting and examples of what can go wrong.

This podcast by Martin Lush focuses on the psychology of human error – why do intelligent and committed people make mistakes? Martin also details best-in-class practices in terms of preventing human error.

In this podcast, Martin Lush draws on his wealth of experience to explain how to approach making controlled and justifiable decisions when under pressure and short of time.

In this short podcast, Catherine Kay details the role of the QP, including what skills and qualities a QP should demonstrate, why QPs are important in your organization and how they can add value.

Podcast

This podcast introduces the CAPA hierarchy which we developed based on an analysis of FDA warning letters.  This simple tool helps investigators identify more robust and effective corrective and preventative actions. Most of us tend to retrain or write additional complexity into plant SOPs. Our CAPA hierarchy pushes investigators to apply a structured approach to identify CAPAs that truly address root cause(s).

Traditional training doesn’t stick, but education does. In this podcast, Martin Lush presents a case study on the 10/20/70 model, illustrating how it works and providing you with practical training tools and techniques that you can use immediately in the workplace.

This podcast will provide you with the tools and techniques to drive out complexity and wet your appetite to win the war against this silent enemy. 

In this podcast, John Johnson details the importance of having a proactive approach to quality risk management. John covers what ICH Q9 requires you to do, why staff behavior is crucial in maintaining a proactive approach to the quality risk management process and three common tools: policy development, failure mode and effects analysis, and contamination control strategy.