Session Information
AABB Annual Meeting and CTTXPO 2013
Click here to go to the previous page
The FDA MDDS Regulation's Impact on Healthcare Organizations
Track
:
TC - Technical/Clinical
Program Code:
9402-TC-IT
Date:
Tuesday, October 15, 2013
Time:
8:30 AM to 10:00 AM
EST
Location:
201/203
DIRECTOR
:
Chloe Scott, MT(ASCP), CQA(ASQ), Senior Consultant, BioQ Solutions
MODERATOR
:
Chloe Scott, MT(ASCP), CQA(ASQ), Senior Consultant, BioQ Solutions
SPEAKER
(S):
Anthony Lee-Kin, PMP, Director, Information System Quality, Blood Systems, Inc.
John Hoffman, Managing Director, QMR, LLC
Rob Hyatt, Director, Clinical Systems QA/RA, Intermountain Healthcare
Description
FDAs Medical Device Data Systems (MDDS) regulation affects healthcare organizations that create or modify an MDDS. They become classified as a medical device manufacturer under the regulation and are subject to the device regulations. This session will provide organizations guidance to determine if they are creating or modifying an MDDS. Both the hospital and blood center prospective will be presented, and the speakers will discuss the responsibilities required for the organizations quality system to manage their MDDS responsibilities.
- Determine if an organization is responsible for compliance with the MDDS regulation.
- Explain the FDA MDDS regulation.
- Identify the organizational responsibilities for managing an MDDS.
| CE Category | CE Value |
|---|---|
| California Clinical Laboratory Personnel | 1.5 |
| California Nurse | 1.8 |
| Florida Laboratory Personnel | 1.8 |
| General Attendee | 1.5 |
| Physician | 1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.
Audio Synchronized to PowerPoint
(Code: 9402-TC-ITAM/9402-TC-ITA/9402-TC-ITM/9402-TC-IT)
Annual Meeting Attendee/AABB Member:$25 USD
Annual Meeting Attendee/Non AABB Member:$40 USD
Non-Attendee/AABB Member:$40 USD
Non-Attendee/Non AABB Member $50 USD - Your Price
This session is a part of:
This session is a part of:
 | Copyright © 2014 by MultiView, Inc. All website graphics, text, design, software, and other works are the copyrighted works of MultiView, Inc. All audio, video, presentation materials, logos and text are the copyrighted works of their respective owners. All Rights Reserved. Any redistribution or reproduction of any materials herein is strictly prohibited. |  |