Summary: This two-hour, interactive workshop (presented by webinar) information on two important parts of a must know for the device industry, the Quality System (QS).
The workshop features two sessions, each consisting of a presentation followed by a question and answer session with a panel of experts on Management Controls and Design Controls. Each presentation will cover the regulatory requirements and best practices for each topic. Participants can email or call with questions during each session’s Question and Answer session.
You can choose to participate in one or both of the sessions. Each session will begin at the scheduled time.
- 1:00 – 2:00 PM – Management Controls
- 2:00 – 3:00 PM – Design Controls
Target Audience: Medical Device Industry, Medical Device Developers, Medical Device Industry Associations
How to Join the Workshop: All participants will attend via webinar
- To View the Workshop (Webinar Link):http://fda.yorkcast.com/webcast/Play/5909f81acb4e44fa8a0acf2d2cdc95f91d
- To Ask Questions by Telephone: +1 (800) 527-1401
The November 3, 2016, 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.