Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
LTR 40: A guest podcast with NAMSA - Part 1
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LTR 40: A guest podcast with NAMSA - Part 1

A conversation with NAMSA where I was invited as a guest speaker to share my views on common risk management challenges in the medical device industry. Part 1 of 2.
Transcript

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Recently, I was invited by Richard Granquist and Linford Leitch from NAMSA to talk about risk management as part of their monthly RA QA Cafe podcast.

In part 1 of a 2 part series, we discussed the following topics in a very open and engaging conversation!

  • How I got into risk management.

  • How I think about risk management in a small vs. large organization.

  • Why risk management is not a paper exercise, it is a process.

  • Why risk management approach should align with business goals.

  • A leadership opportunity for risk practitioners to shape culture.

  • How a systematic approach helps you do risk management well.

  • Risk management is a cross-functional activity; involve regulatory early.

  • Treat risk management not as an add-on but part of your quality system.

  • Documentation is important but we need to make it easy and less burdensome.

Listen to the podcast above and share your views in comments below.

About NAMSA and RA QA Cafe

NAMSA is a leading service provider to the global MedTech industry specializing in CRO (Clinical Research Organization) services, medical device testing capabilities, strategic guidance and tactical support to fast-track market introduction. Learn more about NAMSA, their services and expertise here.

The RA QA Cafe is a conversational podcast where each episode features NAMSA consultants and invited guests to discuss Quality and Regulatory Affairs related topics relevant to the MedTech industry.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

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Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!