An Integrated Approach to Quality Risk Management

Industry experts from Axendia and Sparta Systems discuss the value of quality risk management and its practical applications.

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Managing Risk to Improve Product Quality 

An effective quality risk management program enables Life Science manufacturers to proactively manage product quality and patient safety. Risk management is a top priority for regulators around the world with a special focus on combination products and medical devices.

Beyond compliance, manufacturers can achieve maximum value from their Risk Management program by deeply integrating it to their Quality Management System. In doing so, Life Science manufacturers can unlock process efficiency and enhanced signal and trend detection, leading to improved product quality and reduced patient risk.

In this webinar, learn:

  1. The value of Quality Risk Management: 
    • Why it is an important topic for combination product and medical device manufacturers.
    • Key differences between ICH Q9 and ISO 14971.
    • The new ISO 14971:2019.
    • Considerations when upgrading your Risk Management process.
  2. The benefit of having your QMS connected to your RM program.
  3. Practical applications of AI in Medical Device Risk Management.
Sparta Systems, a Honeywell Company, brings leading-edge quality management solutions to regulated industries. With nearly three decades of experience, Sparta provides enterprise and cloud-based QMS software solutions that help companies go to market faster while minimizing product risks and ensuring compliance. Sparta is an innovator in its field and is driving smart quality with first-of-its-kind AI-enabled quality solutions. By applying the latest digital technologies, our products simplify the process of quality management and guide customers toward proactive quality.

The combination of Sparta Systems and Honeywell brings together Sparta’s quality management leadership with over 100 years of industrial and software expertise from Honeywell. Together, Sparta and Honeywell will shape the future of digital quality and operational excellence for the life sciences industry.