2 Nov, UTM – A half day seminar jointly organised by UTM’s Innovation and Commercialisation Centre (ICC) and the Institute of Bioproduct  Development  (IBD) aims to provide  training and an understanding of what the terminology and requirements are when products are reviewed, sampled, released, or refused entry by the FDA. Michael Kravchuk has an extensive FDA regulatory experience (Inspectional, compliance, supervisory, and manager), 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 FDA 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. Michael Kravchuk has experience in GMP (Food and Drug) and QSR (Device) quality systems from compliance (regulatory) perspectives. Specific areas of expertise include FDA import process and procedures, substantive working knowledge of FDA regulatory requirements for foods, drugs, and medical devices, preparation and responses to Warning Letters and Inspectional Observations (Form FDA 483); preparation for Regulatory Meetings; understanding of Chinese regulatory requirements for medical devices.  Stationed in China as FDA Deputy Country Director between 2008 to 2011, working with regulators, educators, industry and other US government agencies on FDA matters.