Join FDA experts on November 6, 2018 for a live workshop and Q&A on the Quality System
On Tuesday, November 6, CDRH’s Division of Industry and Consumer Education (DICE) will host an Industry Basics Workshop on the Quality System: Production and Process Controls; and Documents, Change Control, and Records.
Manufacturers must establish and follow quality systems to ensure their medical devices are manufactured in a safe and effective manner. This is the 4th annual workshop to focus on parts of the quality systems regulations to help manufacturers meet specifications and bring devices to market.
The Industry Basics Workshop will address each topic in a one-hour session. Each session will feature a presentation followed by a moderated question and answer session with a panel of FDA experts. Audience participants are encouraged to email or call with questions during each session.
Workshop Details:
There is no fee, and registration is not required.
Date: Tuesday, November 6, 2018
Time: 1:00 – 3:00 pm ET
You may choose to participate in one or both sessions.
Each session will begin at the scheduled time below.
1:00 – 2:00 pm ET: Production and Process Controls
2:00 – 3:00 pm ET: Documents, Change Control, and Records
On the day of the workshop, use the following link to join the webinar:
For background about Quality Systems and the Industry Basics Program, we encourage you to view the presentation on Nonconforming Product and Complaint Files.If you have any questions regarding the Industry Basics Workshop, please contact CDRH’s DICE atDICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.
We look forward to your participation on Tuesday, November 6.
Thank You,
Elias Mallis
Director
Division of Industry and Consumer Education
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