On November 3, 2016 from 1:00 to 3:00 PM, Eastern Time, the Center for Devices and Radiological Health’s (CDRH) Division of Industry and Consumer Education (DICE) will host a two-hour, interactive CDRH Industry Basics Workshop on two subsystems of the Quality System (detailed agenda below). There is no fee to attend and registration is not required.
Target Audience: Medical device manufacturers and/or developers seeking the fundamental concepts of medical device quality system regulations.
The workshop features two sessions, each consisting of a presentation followed by a question and answer session with a panel of experts. Participants can email or call with questions during each session’s Question and Answer session.
Schedule of Events (U.S. Eastern Standard Time)
You can choose to participate in one or both of the sessions. Each session will begin at the scheduled time.
You can choose to participate in one or both of the sessions. Each session will begin at the scheduled time.
| Time | Topic | Speaker | Expert Panelist |
|---|---|---|---|
| 1 pm – 2 pm | Management Controls | Tonya Wilbon, OCE | Eric Horowitz, OC |
| 2 pm – 3 pm | Design Controls | Joseph Tartal, OCE |
How to Join the Workshop: All participants will attend via webinar
To View the Workshop (Webinar Link): http://fda.yorkcast.com/
To Ask Questions by Telephone: +1 (800) 527-1401
The CDRH Industry Basics Workshop is not intended to provide submission-specific feedback, so please limit your questions to broad policy questions about the program topics. Submission-specific questions will be referred to the appropriate CDRH program Office for response.
We look forward to your participation on Wednesday, November 3!
For questions about this event, please contact DICE@fda.hhs.gov or call +1 (800)-638-2041 or (301) 796-7100.
For further information about CDRH Industry Educational Resources, please visit the DICE Web Page.
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