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Complimentary Webinar: Medical Device Reporting CFR Title 21, part 803
Medical Device Reporting, CFR Title 21, part 803
There have been some recent important changes regarding FDA visits to facilities. Please join us for this MSHRM-members only informative update on Medical Device Reporting by:
Sherry K. Markwell, RN, BSN, MM, CPHRM
Nurse Consultant, Medical Product Safety Network (MedSun)
FDA/CDRH/OSB/DPSP
Phone: 301-796-6726
Email: [email protected]
Objectives:
- List at least two ways medical device reporting affects patient safety
- Discuss medical device reporting at your facility
- Discuss the Code of Federal Regulations (CFR) Title 21, part 803 as it relates to “user facility” requirements for medical device reporting
This session will discuss how medical device reporting impacts patient safety, including FDA activities that result from medical device reporting. A review of medical device reporting methods as well as reporting requirements set forth in the Code of Federal Regulations Title 21, part 803 as it relates to user facility reporting also will be discussed. Attendees will have the opportunity to hear from a staff member at FDA how medical device reporting impacts patient safety not only at the local facility level, but also at the national level.
The session will provide time for questions and answers; however, if you also are invited to send your questions prior to the session directly to the speaker so that we can answer as many of your questions as possible during the time provided. Please email your questions with the subject line MSHRM directly to Sherry at [email protected].
You do not need to register for this webinar. Here is the login/call in information.
Sherry Markwell invites you to an online meeting using WebEx.
Meeting ID: 742 414 949
Meeting Password: 3017966726
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To join this meeting
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1. Go to https://fda.webex.com/fda/j.php?MTID=mf489810dad57f6b6ac4d017eef3d4fbe
2. If requested, enter your name and email address.
3. If a password is required, enter the meeting password: 3017966726
4. Click "Join".
5. Follow the instructions that appear on your screen.
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Teleconference information
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1. Provide your number when you join the meeting to receive a call back. Alternatively, you can call one of the following numbers:
Local: 1-301-796-7777
toll free: 1-855-828-1770
2. Follow the instructions that you hear on the phone.
Your Cisco Unified MeetingPlace meeting ID: 742 414 949
Technical support:
Contact FDA Rich Media at 301-796-3333.
IMPORTANT NOTICE: This WebEx service includes a feature that allows audio and any documents and other materials exchanged or viewed during the session to be recorded. By joining this session, you automatically consent to such recordings. If you do not consent to the recording, discuss your concerns with the meeting host prior to the start of the recording or do not join the session. Please note that any such recordings may be subject to discovery in the event of litigation.
