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  5. CDRH Industry Basics Workshop: Production and Process Controls; and Documents, Change Control, and Records - November 6, 2018 - 11/06/2018 - 11/06/2018
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Event Title
CDRH Industry Basics Workshop: Production and Process Controls; and Documents, Change Control, and Records - November 6, 2018
November 06, 2018


Date:
November 06, 2018
Time:
01:00 PM - 03:00 PM EST
Location:
Organized By:

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Workshop Materials

Summary:

Manufacturers must establish and follow quality systems to ensure that medical devices are manufactured in a safe and effective manner. The Industry Basics Workshop will feature sessions on two parts of quality system regulation: Production and Process Controls; and Documents, Change Control and Records, to help manufacturers meet applicable requirements and specifications.

Each session will include a presentation, followed by a moderated question and answer session with a panel of CDRH experts. Audience participants are encouraged to email or call with questions during each session.

Participants may choose one or both sessions. Each session will begin at the scheduled time.

1:00 – 2:00pm ET: Production and Process Controls
2:00 – 3:00pm ET: Documents, Change Control, and Records
Target Audience: All medical device manufacturers required to follow 21 CFR 820, Quality System Regulation.

The November 6, 2018, CDRH Industry Basics Workshop is as a general educational forum. It is not intended to provide definitive device or submission specific regulatory feedback, so please limit your questions to broad policy questions about the program topics. If you have specific questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health at 1-800-638-2014, 301-796-7100 or dice@fda.hhs.gov.