Greenlight Guru (Indianapolis) announced that it is presenting a joint-webinar series with the FDA to provide awareness of the FDA’s Case for Quality program.
The Case for Quality programs allows the FDA to work with stakeholders in the healthcare industry, such as manufacturers, healthcare providers, patients, payers and investors. The program helps move the focus from regulatory-only to a collaborative industry partner by recognizing manufacturers that are consistently making high-quality devices.
Case for Quality was launched in 2011 after a review of device quality data and feedback from the FDA and industry stakeholders. Since its launch, the FDA has created programs for stakeholder engagement and has developed a Voluntary Manufacturing and Product Quality appraisal pilot and is also piloting streamlined submission reviews to support improvement. The FDA is also working on clearing real or perceived regulatory approaches that could be 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,” Greenlight Guru’s founder and VP of QA/RA Jon Speer said. “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 joint-webinar series will be presented by the FDA Case for Quality program manager Francisco Vicenty in a partnership with Greenlight Guru. It will present an overview on lessons learned from pilot program participants. Vicenty plans to present evidence that a manufacturer can develop both compliant and effective medical devices through quality. He will also show the specific steps manufacturers can take to have 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 system from the participants,” Vicenty said. “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.”
The webinar series will run from July 11 until October.
- 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 (date to be announced): FDA’s Case for Quality: Simplifying the regulatory activities.
People interested in the webinar series can learn more and register online on Greenlight Guru’s website.