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FDA Driving Industry "Beyond Compliance" to Promote Manufacturing Quality

By Daniel R. Matlis

ADVAMED 2013 lived up to its reputation as “the leading MedTech conference.” One highlight of the event for me was the panel: “Case for Quality FDA & Industry Progress Update”

The “Case for Quality Initiative” is a strategic priority for the US Food and Drug Administration. To support this initiative, the agency is working to implement policies that go beyond compliance with regulations and provide an enhanced focus on manufacturing quality.

This panel examined the results of the FDA initiated Case for Quality. Top FDA and Industry leaders discussed the impact of the recent guidances on this initiative and FDA efforts at transparency. FDA representatives discussed how this program is being rolled out in the field offices and what industry should expect going forward.

The panel was moderated by Judith Meritz, Associate General Counsel, Covidien
Panelists included:

  • Donna Godward, Chief Quality Officer, MD&D, Johnson & Johnson Corporation
  • Joseph Sapiente, VP, Global Quality & Regulatory Operations, Covidien
  • Steven Silverman, Director, CDRH Office of Compliance, FDA
  • Steven Solomon, DVM, MPH, Acting Deputy Associate Commissioner for Regulatory Affairs, FDA/Office of Regulatory Affairs

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To gain a deeper understanding about this strategic shift at the FDA, I recently spoke with Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health.

According to Mr. Silverman, FDA launched this initiative as a fact-based effort that drew from a close review of Agency data and feedback from both the Agency and Industry thought-leaders. The Agency’s analysis flagged manufacturing quality risks as a top issue. It showed that firms that managed those risks by driving quality across the organization tend to be more productive, with fewer complaints and investigations per batch, and often have smaller quality units with lower quality-related costs than their competitors.

Beginning in January, we will publish a series of “Executive Perspective” articles covering our discussion on the Case for Quality Initiative.

  • In Part I of the series, Mr. Silverman provides an overview of the Case for Quality Initiative, and discusses the Agencies drive for sustained conversations with industry to improve device quality.
  • In Part II, we discuss the expected benefits of Case for Quality Initiative for FDA and industry as well as the role metrics and analytics play in supporting the Case for Quality Initiative.
  • In Part III article of this series, Mr. Silverman discusses how firms can demonstrate to the Agency their commitment to quality. We also discuss FDA’s shift from “lagging” to “leading indicators,” and outline next steps for Case for Quality Initiative.
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