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FDA, Medical Device Industry Pros to Discuss Quality at Regulatory Affairs Professionals Society Forum in Irvine, CA

10/25/2012 9:30:25 AM

Rockville, MD, USA—Medical device company executives and US Food and Drug Administration (FDA) officials will gather at the Beckman Center in Irvine, CA, 1 November, for The RAPS/FDA Case for Quality Forum—Los Angeles, presented by the Regulatory Affairs Professionals Society (RAPS). The forum will provide an opportunity for FDA and industry representatives to discuss how to improve the quality of medical devices to advance public health.

The interactive forum will enable members of the medical device community to share their thoughts on best practices, what works and what tends to inhibit quality efforts while hearing directly from FDA about the agency’s Case for Quality initiative, including timelines for short- and long-term goals, mechanisms for stakeholder involvement and plans for how this initiative will be implemented at the national and regional levels.

Scheduled speakers include:

• Alonza Cruse, director, Los Angeles District, FDA (invited)

• Ann Ferriter, director, Division of Risk Management Operations, Office of Compliance, CDRH, FDA

• Donna Godward, vice president, quality, regulatory, compliance, Johnson & Johnson

• Cecilia Kimberlin, vice president, quality and regulatory, Abbott

• William MacFarland, director, Division of Enforcement B, Office of Compliance, CDRH, FDA

• Jan Welch, deputy director for regulatory affairs, Office of Compliance, CDRH, FDA

Members of the working media who wish to cover The Case for Quality Forum should contact Zachary Brousseau, senior manager, communications for RAPS at or +1 301 770 2920, ext. 245.

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide.

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