{"id":966,"date":"2015-11-04T14:35:38","date_gmt":"2015-11-04T06:35:38","guid":{"rendered":"http:\/\/localhost\/dayangzaidel\/?p=966"},"modified":"2016-04-06T10:47:55","modified_gmt":"2016-04-06T02:47:55","slug":"seminar-on-how-to-get-fda-approval","status":"publish","type":"post","link":"https:\/\/people.utm.my\/dayangnorulfairuz\/2015\/11\/04\/seminar-on-how-to-get-fda-approval\/","title":{"rendered":"A half day Seminar on &#8220;How to get a product through FDA approval&#8221;"},"content":{"rendered":"<p style=\"text-align: left\"><strong>2\u00a0Nov, UTM<\/strong> &#8211; A half day seminar jointly <u><\/u>organised<u><\/u> by UTM\u2019s Innovation and <u><\/u>Commercialisation<u><\/u> Centre (ICC) and the Institute of Bioproduct\u00a0 Development\u00a0 (IBD) aims to provide \u00a0training and an understanding of what the terminology and requirements are when products are reviewed, sampled, released, or refused entry by the <span class=\"il\">FDA<\/span>.\u00a0Michael Kravchuk has an extensive <span class=\"il\">FDA<\/span> regulatory experience (Inspectional, compliance, supervisory, and <u><\/u>manager<u><\/u>), and providing compliance consulting services and training to regulators and regulated clients. Recently established the firm Michael Kravchuk, Food, Drug, Device Consultant, LLC after retirement from <span class=\"il\">FDA<\/span> with over 39 years of service. Over past three years he has provided Food training to Chinese, Malaysian, Thai Regulatory authorities, and performed audits of drug and medical device facilities in China, Taiwan and India.\u00a0Michael Kravchuk has experience in\u00a0GMP\u00a0(Food and Drug) and QSR (Device) quality systems from compliance (regulatory) perspectives. Specific areas of expertise include <span class=\"il\">FDA<\/span> import process and procedures, substantive working knowledge of <span class=\"il\">FDA<\/span> regulatory requirements for foods, drugs, and medical devices, preparation and responses to Warning Letters and Inspectional Observations (Form <span class=\"il\">FDA<\/span> 483); preparation for Regulatory Meetings; understanding of Chinese regulatory requirements for medical devices.\u00a0\u00a0Stationed in China as <span class=\"il\">FDA<\/span> Deputy Country Director between 2008 to 2011, working with regulators, educators, industry and other US government agencies on <span class=\"il\">FDA<\/span> matters.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>2\u00a0Nov, UTM &#8211; A half day seminar jointly organised by UTM\u2019s Innovation and Commercialisation Centre (ICC) and the Institute of Bioproduct\u00a0 Development\u00a0 (IBD) aims to provide \u00a0training and an understanding of what the terminology and requirements are when products are reviewed, sampled, released, or refused entry by the FDA.\u00a0Michael Kravchuk has an extensive FDA regulatory &hellip; <a href=\"https:\/\/people.utm.my\/dayangnorulfairuz\/2015\/11\/04\/seminar-on-how-to-get-fda-approval\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">A half day Seminar on &#8220;How to get a product through FDA approval&#8221;<\/span> <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":270,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[51],"tags":[],"class_list":["post-966","post","type-post","status-publish","format-standard","hentry","category-workshop"],"_links":{"self":[{"href":"https:\/\/people.utm.my\/dayangnorulfairuz\/wp-json\/wp\/v2\/posts\/966","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/people.utm.my\/dayangnorulfairuz\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/people.utm.my\/dayangnorulfairuz\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/people.utm.my\/dayangnorulfairuz\/wp-json\/wp\/v2\/users\/270"}],"replies":[{"embeddable":true,"href":"https:\/\/people.utm.my\/dayangnorulfairuz\/wp-json\/wp\/v2\/comments?post=966"}],"version-history":[{"count":0,"href":"https:\/\/people.utm.my\/dayangnorulfairuz\/wp-json\/wp\/v2\/posts\/966\/revisions"}],"wp:attachment":[{"href":"https:\/\/people.utm.my\/dayangnorulfairuz\/wp-json\/wp\/v2\/media?parent=966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/people.utm.my\/dayangnorulfairuz\/wp-json\/wp\/v2\/categories?post=966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/people.utm.my\/dayangnorulfairuz\/wp-json\/wp\/v2\/tags?post=966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}