{"122881":{"#nid":"122881","#data":{"type":"event","title":"Understanding Regulatory Requirements for Human Factors Usability Testing","body":[{"value":"\u003Ctable width=\u0022546\u0022\u003E\u003Ctbody\u003E\u003Ctr\u003E\u003Ctd\u003E\u003Cp\u003EJoin your regulatory colleagues from across the Atlanta area for an afternoon of networking and to hear presentations and a panel discussion entitled, \u201cUnderstanding Regulatory Requirements for Human Factors Usability Testing.\u201d This program will provide attendees with an expert overview of FDA\u2019s latest draft guidance and to ensure that you are up to date on all the new requirements.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.\u003C\/p\u003E\u003Cp\u003EThe 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.\u003C\/p\u003E\u003Cp\u003EThe 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.\u0026nbsp; If you are a device manufacturer you should be performing appropriate human factors engineering and usability testing.\u003C\/p\u003E\u003Cp\u003EThis program will cover all new requirements, including:\u003C\/p\u003E\u003Cul\u003E\u003Cli\u003EFDA perspectives\u003C\/li\u003E\u003Cli\u003EHuman factors usability testing processes and data analysis\u003C\/li\u003E\u003Cli\u003EHuman factors risk management\u2014A corporate overview\u003C\/li\u003E\u003C\/ul\u003E\u003Cp\u003EView the\u0026nbsp;\u003Ca href=\u0022http:\/\/www.raps.org\/education-amp-training\/raps-meetings-amp-education-calendar\/usability-testing-virtual-program-june-2012\/agenda.aspx\u0022\u003EProgram Agenda\u003C\/a\u003E\u003Cstrong\u003E\u0026nbsp;\u003C\/strong\u003Efor a more detailed description of each presentation.\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003EProgram Chair and Moderator:\u0026nbsp;\u003C\/strong\u003E\u003Cbr \/\u003E\u003Cstrong\u003EPenny Northcutt, RAC, FRAPS, CQA\u003C\/strong\u003E, REGSolutions LLC, a company that provides regulatory solutions and quality systems for the life science industry.\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003EPanelists:\u003C\/strong\u003E\u003Cbr \/\u003E\u003Cstrong\u003EMaria Shepherd, MBA\u003C\/strong\u003E, Data Decision Group, a company providing human factors engineering usability testing to the medical products industry.\u003Cbr \/\u003E\u003Cstrong\u003EKathleen Whanger, MS\u003C\/strong\u003E, senior quality engineer at Boston Scientific working on the human factors engineering corporate team.\u003Cbr \/\u003E\u003Cstrong\u003EMolly Follette Story, PhD\u003C\/strong\u003E, a human factors and accessible medical technology specialist, one of three full\u2010time human factors reviewers in the Center for Devices and Radiological Health, Office of Device Evaluation, FDA.\u003C\/p\u003E\u003Cp\u003E\u003Ca href=\u0022http:\/\/www.raps.org\/education-amp-training\/raps-meetings-amp-education-calendar\/usability-testing-virtual-program-june-2012\/speakers.aspx\u0022\u003ESpeaker Bios\u003C\/a\u003E\u003C\/p\u003E\u003Cp\u003E\u003Ca href=\u0022http:\/\/www.raps.org\/publications-amp-resources\/raps-store\/product-detail.aspx?ProductID=2876428\u0022\u003ERegister today\u003C\/a\u003E\u003C\/p\u003E\u003C\/td\u003E\u003C\/tr\u003E\u003C\/tbody\u003E\u003C\/table\u003E","summary":null,"format":"limited_html"}],"field_subtitle":"","field_summary":"","field_summary_sentence":[{"value":"This program will provide attendees with an expert overview of FDA\u2019s latest draft guidance and to ensure that you are up to date on all the new requirements."}],"uid":"27414","created_gmt":"2012-04-09 09:50:18","changed_gmt":"2016-10-08 01:58:41","author":"Maribel Baker","boilerplate_text":"","field_publication":"","field_article_url":"","field_event_time":{"event_time_start":"2012-06-07T17:00:00-04:00","event_time_end":"2012-06-07T21:30:00-04:00","event_time_end_last":"2012-06-07T21:30:00-04:00","gmt_time_start":"2012-06-07 21:00:00","gmt_time_end":"2012-06-08 01:30:00","gmt_time_end_last":"2012-06-08 01:30:00","rrule":null,"timezone":"America\/New_York"},"extras":[],"groups":[{"id":"67773","name":"IBB Center - TRIBES"}],"categories":[],"keywords":[],"core_research_areas":[],"news_room_topics":[],"event_categories":[],"invited_audience":[],"affiliations":[],"classification":[],"areas_of_expertise":[],"news_and_recent_appearances":[],"phone":[],"contact":[{"value":"\u003Cp\u003E\u003Ca href=\u0022mailto:education@raps.org\u0022\u003Eeducation@raps.org\u003C\/a\u003E\u003C\/p\u003E","format":"limited_html"}],"email":[],"slides":[],"orientation":[],"userdata":""}}}