Regulatory Policy

FDA, Academia, and Industry Working Together to Improve Quality – Workshop & Series

Friday, April 8, 2016. FDA LOS-DO Main Conference Room at 19701 Fairchild Drive, Irvine, CA 92612

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.

Graduate students from the University of Southern California (USC) – Local Regulatory Policy Graduate Program contribute to this effort by making available to a general audience a summary of the presentations conducted during the first workshop.  Those presentations discuss current challenges with regulated product quality and the use of quality tools to address those issues.

PDF Documents available on hyperlinks

  1. Reusing Single Use Devices: Three PerspectivesSpeaker: David Locke, DRSc, Doctoral graduate, USC
  2. FDA Mission and VisionSpeaker: William Martin, PhD, Acting Director for Pacific Region, FDA
  3. How FDA Conducts Import Operations at the US Ports and its role in Consumer ProtectionSpeaker: Dan Solis, Director of Import Operations, Los Angeles District.
  4. FDA Regulatory Policy Process and Current TrendsSpeaker: Marlène García Swider, PhD, Quality System Manager, FDA Los Angeles District

Sharing is Caring:

Quality Leaders is sponsored by MEIRxRS’s