We are evolving, now we are Quality Leaders. The ASQ FDC Division is the proud sponsor of qualityleaders.org. This website, “Quality Leaders,” is maintained in association with the Quality Leaders Network (QLN) group. Its purpose is to provide a space that allows academia, industry, and FDA to exchange information, to network, to collaborate, and to communicate topics of common interest. Quality Leaders initiated activities as easyfsma.com created to assist small to mid-size companies to comply with the Food Safety Modernization Act signed by President Obama. Recently the website expanded to support other QLN subgroups. During the 2016 summer, Quality Leaders will add a periodic publication that will offer study summaries, key points, and other informative and educational material related to the FDA’s scope, including but not limited to public health issues, regulations, and their programs and activities. This enhancement will be led by the University of Southern California’s Regulatory Science Program.
The Institute of Food Technologists (IFT) Magazine’s March-2016 issue published the “Scorecard Tool Assists with FSMA Compliance” paper created by the QLN Metrics Group. Food Technology Magazine is the leading publication addressing all facets of food science and technology. The paper and corresponding scorecard are also available on the Tools section of Quality Leaders. Link to the Scorecard Tool Assists with FSMA Compliance paper.
In an effort to ensure full transparency with the medical product and dietary supplement industries, the FDA Los Angeles District Office is hosting a Regulatory Policy Lecture Series on how FDA goes about improving product, processes, and service quality through the use of quality tools. During cGMP investigations and through import inspections, FDA has noted several areas where industry could improve product quality. We will share our observations with future regulatory policy professionals and graduate students from local regulatory policy graduate programs. The audience for these lectures includes graduate program students from USC, UCI, Tech Graduate Institute, Chapman University and Cal Poly Pomona. Many of these students are pursuing careers with FDA as employees or quality interns. These workshops will include presentations by FDA quality interns and FDA subject matter experts discussing our current challenges with product quality and use of quality tools to address these quality issues. For more information, download our booklet.
The FDA’s Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled “Navigating CDER: What You Should Know for Effective Engagement.” on March 31, 2016. The purpose of this public workshop is to help the public and patient advocacy groups gain a better understanding of how to effectively engage CDER. More information here