ORA Meeting: Cultivating Compliance

Virtual Event: Cultivating Compliance Conference for Industry

Date: September 01, 2020
Time: 11:00 AM to 4:30 PM EDT

The FDA Office of Medical Device and Radiological Health Operations is hosting this one-day, virtual event from 11:00 AM to 4:30 PM EDT.  Spaces are limited  to 700, and registration is required. 

Cultivating Compliance is designed to provide insight to the major challenges OMDRHO sees during inspections of the regulated device and radiological health industries and to provide insight and ideas for improving compliance with FDA regulations.

Our goal is to provide important information that might be of strategic use to you as a manufacturer of medical devices. Subject matter experts from both ORA and CDRH will entertain address participant questions and explore the current trends of 483 observations, warning letters and firm responses to both; CAPA, Design Controls, Design Changes, and Recalls.  Presenters will also provide tips for documentation that FDA requires.  

Though attendance at the event is free, registration is limited to one line per Corporation, based on availability.  The deadline for registering is August 21.  

Registration Information: To register, email ORAMedDeviceConference@fda.hhs.gov, and include the following information:
    Company Name
    Company city and state
    Max. 1 line per firm Names & Titles
    Attendee(s) email address
    Attendee(s) phone number

Workshop Materials: Agenda

Presentations:

• Office of Medical Devices and Radiological Health Recalls
  Meredith Andress
• Current Compliance Trends in OMDRHO
  Karen Archdeacon
• Corrective and Preventive Action Subsystem
  Laiza V. Garcia
• Premarket Submissions Including Design Changes
  Dharmesh Patel
• Design Controls: Cultivating Compliance Virtual Conference
  Matthew M. Vernon, PhD

The conference will be held via Cisco Webex. For more information about Webex visit https://help.webex.com/contact?language=en-us