FDA and Greenlight Guru Announce Case for Quality Webinar Series

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Series aims to make case for, and share lessons from, Case for Quality program

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There is a paradigm shift in our industry as more companies are beginning to see the value of having a true quality mindset. The best medical device companies don't just follow the rules, they lead with quality.

Greenlight Guru, the only cloud-based quality management software specifically for medical device companies, today announced a joint-webinar series with the U.S. Food & Drug Administration (FDA). The four-part webinar series is designed to spread awareness of the FDA’s Case for Quality program.

The Case for Quality program allows the FDA to work with stakeholders—manufacturers, healthcare providers, patients, payers and investors—to shift focus from regulatory-only to a collaborative industry partner, recognizing manufacturers that consistently produce high-quality devices. This dynamic shift is one of the FDA’s strategic initiatives and emphasizes the importance of producing quality devices and continuously improving rather than simply checking regulatory requirements.

The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. Since then, the FDA has established mechanisms for stakeholder engagement, developed a Voluntary Manufacturing and Product Quality appraisal pilot, and is piloting streamlined submission reviews to support the continuous improvement.

FDA is also working to clear any real or perceived regulatory approaches that may be acting as barriers to quality.

"One of Greenlight Guru’s core values is ‘quality.’ The very top performing medical device companies view quality as a competitive advantage," says Greenlight Guru founder and VP of QA/RA Jon Speer. “There is a paradigm shift in our industry as more companies are beginning to see the value of having a true quality mindset. The best medical device companies don't just follow the rules, they lead with quality.”

The webinar series is presented by FDA Case for Quality Program Manager Francisco Vicenty in partnership with Greenlight Guru and will present an overview on lessons learned from pilot program participants. Vicenty will present evidence that through quality, a manufacturer can develop both compliant and effective medical devices. He will also present specific steps manufacturers can take to adopt a quality-first mindset.

"Working with nearly 30 sites during the Case for Quality pilot, we have seen dramatic shifts in the improvement activities and the impact on the quality systems from the participants,” says Vicenty. “As an organization that has shared this quality sentiment, we are partnering with Greenlight Guru to spread our message of quality, not just regulation. The majority of participants find that this shift in focus and the dynamics of the appraisal allows them to focus on proactive improvements, not just reacting to issues.”

Series topics will include:
July 11 – FDA’s Case for Quality: What, Why, and How? Changing the Regulatory Paradigm.
August 16 – FDA’s Case for Quality: Voluntary Pilot Program Details and Status Update.
September 20 – FDA’s Case for Quality: Pilot Summary, Learnings, and Next Steps.
October TBD – FDA’s Case for Quality: Simplifying the Regulatory Activities.

To learn more about the series and register for the upcoming webinars, please visit http://www.greenlight.guru/webinar/fda-case-for-quality.

About Greenlight Guru
Greenlight Guru is the only quality management platform designed specifically for medical devices companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance achieving True Quality. For more information, visit http://www.greenlight.guru.

About the Food and Drug Administration
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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