Let's Combinate - Drugs + Devices13 Maalis 2024

127 - BIG Risk Management Changes in QMSR, Risk Acceptability, Risk Policy & Explaining vs. Justifying Risk Decisions with Naveen Aggarwal

On this episode I was joined by Naveen Aggarwal founder of Creative Analytic Solutions and host of "Let's talk risk".

In this episode, Naveen walks through the big changes to risk management with the QMSR, and risk beyond safety. The episode covers the confusion surrounding the mandatory nature of risk management in particular and we spend the second half of the episode talk about risk acceptability charts, risk & quality policy, explaining vs. justifying risk based decision making with regards to the traffic light charts that most companies use for risk acceptance.

Episode Chapters:

02:00 Interpreting the QMSR and Its Implications

05:56 Impact of QMSR on Risk Management

08:34 Risk Management in Practice

12:09 Insights from FDA Inspections and Warning Letters

23:30 The Importance of Process-Based Approach

24:57 Deep Dive into Risk Policy and Risk Acceptability

26:05 Understanding the Framework of 14971

26:42 The Role of Quality Policy in Risk Management

27:32 Risk Control

29:47 Risk Acceptability in Risk Policy

30:59 Understanding Risk Matrix

32:16 Risk Control and Quality Policy

41:00 Understanding Risk Acceptability Charts

Naveen Agarwal PhD is an Engineer by training with nearly 20 years of professional experience in Product Development, Quality Systems and Data Analytics. As a result, he's developed a very broad and deep expertise in all of the core functions involved in the entire lifecycle of medical products. Naveen joins us from Creative Analytics Solutions where his mission is Helping Medical Companies Build Safe Products. Naveen is a PhD Polymer scientist turned QM consultant and expert.

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