Top 5 LTR Podcasts

Catch up on the most popular Let's Talk Risk! conversations in case you missed them.

Naveen Agarwal, Ph.D.

Jun 14, 2024

LTR 35: Tips for improving collaboration in risk management

Naveen Agarwal, Ph.D.

Jan 12

LTR 35: Tips for improving collaboration in risk management

The practice of risk management in a heavily regulated industry such as medical devices is hard. There are many challenging questions that must be resolved in a simple way that is both sensible and defensible to demonstrate compliance with regulatory requirements.

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LTR 33: AI and the future of work for QA/RA professionals

Naveen Agarwal, Ph.D.

December 22, 2023

LTR 33: AI and the future of work for QA/RA professionals

Artificial Intelligence (AI) now affects almost every aspect of our personal and professional life. It is also changing the way we work, especially in the knowledge industry. According to a recent report from McKinsey Global Institute about the generative AI and the future of work, 30% of the hours worked in many professional activities across the US ec…

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LTR 43: Tips for integrating risk analysis with design controls

Naveen Agarwal, Ph.D.

Mar 8

LTR 43: Tips for integrating risk analysis with design controls

One of the key requirements of ISO 13485, the International Standard for medical device Quality Management Systems is establish a link between risk management and the design and development process. In practice this proves to be quite challenging. In this Let’s Talk Risk! conversation, Chuck Ventura shares that medical device design and development proce…

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LTR 34: Build a culture of Quality to achieve inspection-readiness at all times

Naveen Agarwal, Ph.D.

Jan 5

LTR 34: Build a culture of Quality to achieve inspection-readiness at all times

The news of an FDA investigator showing up unannounced at a medical device manufacturing facility generally sends a wave of panic throughout the organization! Even when it is a planned inspection, or an audit visit from a notified body, there is a high level of stress before, during and after the inspection. A lot of effort is spent in “getting ready” f…

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LTR 39: Overcoming challenges in linking risk management with design controls

Naveen Agarwal, Ph.D.

Feb 9

LTR 39: Overcoming challenges in linking risk management with design controls

A common challenge for risk practitioners in the medical device industry is to efficiently link their risk management process with the design controls process. The output of risk management activities needs to be linked to the design process before design inputs are finalized. However, this proves to be quite challenging in practice. One reason is that a…

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Top 5 LTR Podcasts

Catch up on the most popular Let's Talk Risk! conversations in case you missed them.

LTR 35: Tips for improving collaboration in risk management

LTR 33: AI and the future of work for QA/RA professionals

LTR 43: Tips for integrating risk analysis with design controls

LTR 34: Build a culture of Quality to achieve inspection-readiness at all times

LTR 39: Overcoming challenges in linking risk management with design controls

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