Understanding Regulatory Requirements for Human Factors Usability Testing

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Contact

education@raps.org

Summaries

Summary Sentence: This program will provide attendees with an expert overview of FDA’s latest draft guidance and to ensure that you are up to date on all the new requirements.

Full Summary: No summary paragraph submitted.

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 This program will provide attendees with an expert overview of FDA’s latest draft guidance and to ensure that you are up to date on all the new requirements.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:

  • FDA perspectives
  • Human factors usability testing processes and data analysis
  • Human factors risk management—A corporate overview

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.

Speaker Bios

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Status
  • Created By: Maribel Baker
  • Workflow Status: Published
  • Created On: Apr 9, 2012 - 5:50am
  • Last Updated: Oct 7, 2016 - 9:58pm