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There is now a CONTENT FREEZE for Mercury while we switch to a new platform. It began on Friday, March 10 at 6pm and will end on Wednesday, March 15 at noon. No new content can be created during this time, but all material in the system as of the beginning of the freeze will be migrated to the new platform, including users and groups. Functionally the new site is identical to the old one. webteam@gatech.edu
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Join your regulatory colleagues from across the Atlanta area for an afternoon of networking and to hear presentations and a panel discussion entitled, “Understanding Regulatory Requirements for Human Factors Usability Testing.” This program will provide attendees with an expert overview of FDA’s latest draft guidance and to ensure that you are up to date on all the new requirements. This meeting is sponsored by the RAPS Atlanta Chapter to promote knowledge advancement and facilitate networking among local regulatory professionals.
The panelists for this virtual program will be presenting from all over the country. But participants at this Atlanta Chapter event will hear the presentation of Maria Shepherd, MBA live and in-person.
The guidance, released on 22 June, 2011, stated that, as part of design control, medical products manufacturers must conduct a risk analysis to assess and mitigate risks associated with device use. If you are a device manufacturer you should be performing appropriate human factors engineering and usability testing.
This program will cover all new requirements, including:
View the Program Agenda for a more detailed description of each presentation.
Program Chair and Moderator:
Penny Northcutt, RAC, FRAPS, CQA, REGSolutions LLC, a company that provides regulatory solutions and quality systems for the life science industry.
Panelists:
Maria Shepherd, MBA, Data Decision Group, a company providing human factors engineering usability testing to the medical products industry.
Kathleen Whanger, MS, senior quality engineer at Boston Scientific working on the human factors engineering corporate team.
Molly Follette Story, PhD, a human factors and accessible medical technology specialist, one of three full‐time human factors reviewers in the Center for Devices and Radiological Health, Office of Device Evaluation, FDA.
