As part of its commitment to the medical device community, Xavier University will host a special FDA National Forum (FDANationalForum.com) to gain stakeholder input on the top strategic priorities of the Office of Compliance on April 30 at Xavier University.
The FDA National Forum, titled The Case for Quality, will focus on the Quality, Transparency and FDA Engagement with Stakeholders. The Forum is designed to help the FDA identify and prioritize systemic practices that advance device quality. Led by Steve Silverman, Director of the Office of Compliance of the Center for Devices and Radiological Health (CDRH), stated goals for the initiative include working with the industry to change the focus from “regulatory compliance” to “creating a quality product.” To achieve this goal, the FDA will work with industry to prioritize the focus that will have the most impact to increased product quality and increased patient safety.
The Forum is open to industry professionals, academics and government officials. For complete information and to register, visit: www.FDANationalForum.com.
The one-day FDA National Forum immediately precedes the FDA/Xavier University MedCon Conference, April 30-May 3.
For 2.5 days, MedCon 2013 will draw leading FDA officials, industry CEOs, congressional representatives and global industry experts to address topics such as: the FDA Safety and Innovation Act: New requirements and FDA Expectations; the Case for Quality Initiative: How will this impact you?; new 510(k) and PMA guidance, new MDUFA III requirements, the Pre-submission Program, Quality System Inspection Technique, top priorities of the FDA Office of Device Evaluation; tips on how to prepare for the Unique Device Identification final ruling; and a Total Product Lifecycle Case Study by the FDA focusing on Post-Market Surveillance, Risk Management, CAPA, and Design. (www.XavierMedCon.com)
Xavier also leads the QARA Institute for Medical Device Professionals, which focuses education on a Total Product Lifecycle approach to Quality Assurance and Regulatory Affairs. A complete series of educational programs designed by medical device experts is available now. (www.QARAInstitute.com)