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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.

The Engineering Accreditation Council (EAC) is a delegated body by the Board of Engineers Malaysia as the only recognized accrediting body for engineering degree programmes offered in Malaysia. Membership of the EAC comprises five (5) stakeholders namely, the Board of Engineers (BEM) [5-6 representatives], the Institution of Engineers Malaysia (IEM) [5-6 representatives], Industry Employers [3-4 representatives], Malaysian Qualification Agency (MQA) [1 representative] and the Public Service Department (JPA) [1 representative].

The EAC has provided leadership and quality assurance in engineering higher education since 2000. The EAC accredits 190 programmes at 26 institutions of higher learning (IHL) nationwide.

The EAC has been strengthened with respect to its administrative arm with the set up of the Engineering Accreditation Department. The Department presently operates at the Kelana Jaya office. The set up includes a director, seven (7) associate directors, six administrative personnel. The Department is also supported by its committees that oversee the development of the Manual, the outcome-based culture change at institutions of higher learning, quality assurance and international affairs.

On 18th June 2009 the Board of Engineers Malaysia was accepted as the 13th signatory of the Washington Accord. The EAC was instrumental in ensuring Malaysia’s EAC accredited engineering programmes are substantially equivalent to the engineering degrees of the signatories of the Washington Accord.   (Source: http://www.eac.org.my/web/about_EAC.html)

The Faculty of Chemical Engineering has been accredited for 3 years for the last EAC visit in 2013. For the next accreditation, we have been conducting a workshop for preparing the documentation for the next EAC visit in 2016. Hopefully, this time our program will get 5 years accreditation from the council.

On 26th August 2015, an International Food Safety and Security Workshop 2015 has been organized by Food and Biomaterial Engineering Research Group (FoBERG) in collaboration with Asia-Pacific Institute Food Professionals (APIFP). The one-day workshop was held in UTM involving about 50 participants from local universities and professionals. The speakers were Prof. William Riley, Dr. Malik Altaf, Prof Dr. Ida Idayu and Mr. Andy Seet.