{"id":19,"date":"2022-03-10T03:57:50","date_gmt":"2022-03-10T03:57:50","guid":{"rendered":"http:\/\/kimwalkerconsulting.com\/?page_id=19"},"modified":"2022-03-10T03:59:33","modified_gmt":"2022-03-10T03:59:33","slug":"about","status":"publish","type":"page","link":"https:\/\/kimwalkerconsulting.com\/index.php\/about\/","title":{"rendered":"About"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"19\" class=\"elementor elementor-19\" data-elementor-settings=\"[]\">\n\t\t\t\t\t\t\t<div class=\"elementor-section-wrap\">\n\t\t\t\t\t\t\t<header class=\"elementor-section elementor-top-section elementor-element elementor-element-23c734f elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"23c734f\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5d11ff8\" data-id=\"5d11ff8\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d8f6194 elementor-invisible elementor-widget elementor-widget-heading\" data-id=\"d8f6194\" data-element_type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInDown&quot;}\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.5.6 - 28-02-2022 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">About Us<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/header>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-44c93d0 elementor-section-content-top elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"44c93d0\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-970d13b\" data-id=\"970d13b\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-9a1aa09 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9a1aa09\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-ec9bc3c\" data-id=\"ec9bc3c\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eecc3b3 elementor-widget elementor-widget-heading\" data-id=\"eecc3b3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Kim Walker, MS, RAC (US &amp; EU), FRAPS is an independent Global Regulatory, Quality, and Clinical Consultant.<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9091532 elementor-widget elementor-widget-heading\" data-id=\"9091532\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Kim opened Kim Walker Consulting in 2006. In her consulting practice, she assists clients with pre- and post-market regulatory, clinical, and quality system issues. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments.<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-de3a734\" data-id=\"de3a734\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5c4bc62 elementor-widget elementor-widget-accordion\" data-id=\"5c4bc62\" data-element_type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.5.6 - 28-02-2022 *\/\n.elementor-accordion{text-align:left}.elementor-accordion .elementor-accordion-item{border:1px solid #d4d4d4}.elementor-accordion .elementor-accordion-item+.elementor-accordion-item{border-top:none}.elementor-accordion .elementor-tab-title{margin:0;padding:15px 20px;font-weight:700;line-height:1;cursor:pointer;outline:none}.elementor-accordion .elementor-tab-title .elementor-accordion-icon{display:inline-block;width:1.5em}.elementor-accordion .elementor-tab-title .elementor-accordion-icon svg{width:1em;height:1em}.elementor-accordion .elementor-tab-title .elementor-accordion-icon.elementor-accordion-icon-right{float:right;text-align:right}.elementor-accordion .elementor-tab-title .elementor-accordion-icon.elementor-accordion-icon-left{float:left;text-align:left}.elementor-accordion .elementor-tab-title .elementor-accordion-icon .elementor-accordion-icon-closed{display:block}.elementor-accordion .elementor-tab-title .elementor-accordion-icon .elementor-accordion-icon-opened,.elementor-accordion .elementor-tab-title.elementor-active .elementor-accordion-icon-closed{display:none}.elementor-accordion .elementor-tab-title.elementor-active .elementor-accordion-icon-opened{display:block}.elementor-accordion .elementor-tab-content{display:none;padding:15px 20px;border-top:1px solid #d4d4d4}@media (max-width:767px){.elementor-accordion .elementor-tab-title{padding:12px 15px}.elementor-accordion .elementor-tab-title .elementor-accordion-icon{width:1.2em}.elementor-accordion .elementor-tab-content{padding:7px 15px}}<\/style>\t\t<div class=\"elementor-accordion\" role=\"tablist\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-9671\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"tab\" aria-controls=\"elementor-tab-content-9671\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Pre-Market Submission Experience<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-9671\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-9671\"><p class=\"p1\">Includes creating and negotiating EUA, 510(k), PMA, HDE, CLIA, IDE, Q-Sub, IND, Pre-IND, BLA, ANDA, CE Mark Technical File\/Dossier, Health Canada, and various other global regulatory submissions. Recently, she assisted the World Health Organization (WHO) as an Innovation COVID-19 Response Team Consultant and Operations Support &amp; Logistics Supply Team Consultant, where she evaluated regulatory and quality system preparedness for COVID-19 medical devices and IVDs for WHO placement in <span class=\"s1\">under<\/span><span class=\"s2\">&#8211;<\/span><span class=\"s1\">served <\/span>countries.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-9672\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"tab\" aria-controls=\"elementor-tab-content-9672\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Quality System Auditing Experience<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-9672\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-9672\"><p class=\"p1\">Includes GLP, GCP, cGMP, QSR, ISO 13485, ISO 14971, PAI, MDSAP, Australia TGA, Health Canada, and Japan MHLW audits.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-9673\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"tab\" aria-controls=\"elementor-tab-content-9673\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Clinical Trial Experience<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-9673\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-9673\"><p class=\"p1\">Includes creating protocols, investigator brochures, clinical management procedures, conducting GCP audits, writing and negotiating Pre-IND<span class=\"s1\">s<\/span>\/IDEs, writing and negotiating IND<span class=\"s1\">s<\/span>\/IDEs, and writing and negotiating various pre-market submissions containing clinical data. She has participated in and\/or managed the following types of clinical studies: IVDs, medical devices, biologics, pharmaceutical, and combination products. Kim has extensive negotiation experience with the FDA and other global regulatory authorities.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-9674\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"tab\" aria-controls=\"elementor-tab-content-9674\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Teaching Experience<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-9674\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-9674\"><p class=\"p1\">Kim participated on the UC Irvine Extension Life Science Advisory Committee for three years. Additionally, Kim guest lectured for the CSULA \u201cFrom Concept to Market\u201d BIOL 454L and UCSD \u201cRegulatory Strategies for Combination Products with Medical Devices\u201d courses. She participated on the CSUPERB Advisory Committee, Development Team for the Project Management in Clinical Trials Certificate Program through the California State University system. She was the instructor for the \u201cPre-Market Submission\u201d course and co-instructor for the \u201cRegulatory Requirements for Medical Products\u201d course. Kim was also an instructor for the \u201cRegulatory Requirements for Pharmaceutical Products\u201d course and a co-instructor for the \u201cTechnical Writing for the Medical Product Industry\u201d course at the University of California Irvine Extension. She also re-developed and currently teaches the \u201cMedical Device Regulations\u201d course for the San Diego State University (SDSU) Master of Science in Regulatory Affairs program. Kim developed and has taught since 2016 an undergraduate \u201cMedical Product Regulations: Bench to Bedside\u201d course at CSUF with a focus on stem cell therapies, through a California Institute for Regenerative Medicine (CIRM) grant program. She <span class=\"s1\">develop<\/span><span class=\"s2\">ed <\/span><span class=\"s1\">and t<\/span><span class=\"s2\">aught <\/span>the \u201cIntroduction to Regulatory Affairs\u201d course at Roseman University\u2019s <span class=\"s2\">College of Graduate Studies<\/span>.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-9675\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"tab\" aria-controls=\"elementor-tab-content-9675\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Professional Associations<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-9675\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-9675\"><p class=\"p1\">Kim has served on the Orange County Regulatory Affairs Discussion Group (OCRA) Program Committee since 2003. She taught at and managed the OCRA<span class=\"Apple-converted-space\">\u00a0<\/span>US RAC Study Group from 2004\u20132008 and the EU RAC Study Group 2004-2005. Kim was elected as the OCRA Annual Meeting Chair where she managed, moderated, and presented at the 2006 and 2007 2-day FDA-OCRA Annual Conferences with an average attendance of ~325 regulatory, quality, clinical, and government professionals. Additionally, she served on the OCRA Board of Directors 2004-2010 and 2019 and was the 2008-2009 President. Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups. She has managed, presented at and\/or moderated at several professional conferences and educational institutions on clinical, regulatory, and quality topics. She also has participated in the SDRAN Mentoring Program since 2009.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-9676\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"tab\" aria-controls=\"elementor-tab-content-9676\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Certification, Awards, and Education<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-9676\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-9676\"><p class=\"p1\">Kim achieved both the US and EU Regulatory Affairs Professional Society (RAPS) Regulatory Affairs Certifications and has been accepted as a RAPS Fellow in recognition of her contributions and leadership in advancing the regulatory profession. Additionally, Kim received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development. She received a Leveraging Collaboration Award from the FDA for being the industry originator of the LOS-DO Quality Leadership Network (QLN), helping to bridge communication and collaboration opportunities between FDA and industry. <span class=\"s1\">She was awarded a lifetime membership by OCRA in 2017 and SDRAN in 2022.<\/span><\/p><p class=\"p1\">Kim has a Bachelor of Science degree in Bio-Medical Sciences and a Master of Science degree in Regulatory Affairs.<span class=\"Apple-converted-space\">\u00a0<\/span><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>About Us Kim Walker, MS, RAC (US &amp; EU), FRAPS is an independent Global Regulatory, Quality, and Clinical Consultant. Kim opened Kim Walker Consulting in 2006. In her consulting practice, she assists clients with pre- and post-market regulatory, clinical, and quality system issues. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":[],"_links":{"self":[{"href":"https:\/\/kimwalkerconsulting.com\/index.php\/wp-json\/wp\/v2\/pages\/19"}],"collection":[{"href":"https:\/\/kimwalkerconsulting.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/kimwalkerconsulting.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/kimwalkerconsulting.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/kimwalkerconsulting.com\/index.php\/wp-json\/wp\/v2\/comments?post=19"}],"version-history":[{"count":4,"href":"https:\/\/kimwalkerconsulting.com\/index.php\/wp-json\/wp\/v2\/pages\/19\/revisions"}],"predecessor-version":[{"id":25,"href":"https:\/\/kimwalkerconsulting.com\/index.php\/wp-json\/wp\/v2\/pages\/19\/revisions\/25"}],"wp:attachment":[{"href":"https:\/\/kimwalkerconsulting.com\/index.php\/wp-json\/wp\/v2\/media?parent=19"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}