- November 07, 2017
08:00 AM - 10:00 AM EST
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Summary: This workshop will provide information on the fundamental concepts of dealing with Nonconforming Product and Complaint Files.
The workshop features two sessions, each consisting of a presentation followed by a question and answer session with a panel of experts from the Office of Compliance and Office of Communication and Education. Participants can send their questions by email or phone during the Question and Answer sessions.
Participants may choose one or both sessions. Each session will begin at the scheduled time.
1:00 – 2:00 PM – Nonconforming Product
2:00 – 3:00 PM – Complaint Files
Target Audience: All medical device manufacturers required to follow 21 CFR 820, Quality System Regulation.
There is no fee to attend and registration is not required.
How to Join the Workshop: All participants attend via webinar, see link below
The November 7th, 2017, 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.