Supporting your growth objectives

SPI USA, Inc. is an international consulting and training company with a diverse range of experience and expertise. The company offers clients high quality services centered on developing a strategic course that supports the growth objectives of the client.

Resulting from a merger of Dr. Antonio Moreira’s more than 25 years of biotechnology experience and a successful innovative technology-based European consulting firm, SPI USA, Inc. has established itself as a reliable and effective provider of tailored consulting and training services.

SPI USA offers open enrollment training seminars at US and International locations on topics of relevance to the biotech and pharmaceutical industries such as GxP, Medical Devices, Biomanufacturing and Biosafety. These seminars provide clients with the necessary competitive edge to remain successful in highly dynamic industries. SPI USA training seminars are well known for their highly experienced and educated instructors as well as their small class sizes. These small, participant centered seminars, allow for a greater interaction with the instructor. Such courses include:

Biomanufacturing - focuses on the topics of fermentation, cell culture, separations and purification. It is designed to explain why and how bioprocessing is able to produce complex protein products starting from simple microorganisms and cells. The course is presented in practical terms and includes many examples that illustrate basic principles.

Good Clinical Practices (GCP) - provides a review of FDA and ICH guidelines pertaining to GCPs and also provides insight into the roles of the individual members of the clinical research team.

Applications of CGMPs to Biomanufacturing - begins by discussing in detail the FDA organizational structure and the CGMP regulations. It provides a broad overview of CGMP compliance ranging from the FDA’s CGMP regulations through other FDA documents and industry best practices. The course also provides up-to- date regulatory information from other regulatory authorities.

Medical Devices Regulations and Approvals: Quality Systems and Combination Products - covers the key fundamentals for medical device companies to be granted clearance from the US FDA to market their products.

Good Laboratory Practices (GLP) - details the regulatory requirements for Good Laboratory Practices compliance in organizations involved with pre-clinical studies used in support of regulatory submissions. Participants learn how to implement a GLP system, including facilities and equipment, personnel requirements, and test methods development.

Biosafety – details bloodbourne pathogen regulation, principles of biosafety level containment, biosecurity and management of waste disposal.

SPI USA also provides customized on-site training seminars tailored specifically to accommodate a company’s unique needs. SPI USA has trained many staff from large biotechnology and pharmaceutical companies, government agencies, CRO’s and small start up companies. SPI USA’s on-site training portfolio includes GCP training, with customization for Class 1 medical devices, for a major medical device company as well as courses focused on maintaining a state of GMP and GLP compliance for multiple US government agencies and private sector companies.

SPI USA has also formed many beneficial partnerships to further strengthen the education and training of the biotechnology and pharmaceutical industry workforce. The University of Maryland Baltimore County has partnered with SPI USA to provide industry training programs to many agencies. SPI USA’s training seminars are accredited for Continuing Education Units through this partnership as well. Just recently, the Northeast Biomanufacturing Institute partnered with SPI USA to provide training to the Northeast region’s established and ever-growing biopharma sector. SPI USA will conduct the following 2-day training seminars this year: Applications of CGMPs to Biomanufacturing and Medical Devices Regulations & Approvals: Quality Systems & Combination Products. SPI USA has also recently established an agreement with the University College Cork located in Cork, Ireland to conduct various training seminars. The first seminar, Applications of CGMPs to Biomanufacturing, is scheduled for this year.

SPI USA has developed an interactive, multimedia, computer-based CGMP training software package, entitled BioGMP™: GMP Training for Biotechnology, designed specifically for the biotechnology and pharmaceutical industries. The main features of BioGMP™ are its 24/7 availability, self-paced training, modular format, skills assessment capabilities, accompanying text manual, practical examples and its CD-ROM based delivery.

BioGMP™ provides the trainee with consistent training content enabling the trainee to take more responsibility for his/her own learning and become a more efficient and effective learner. Given BioGMP™’s CD-ROM delivery, it allows the trainee to take training from home, the office or on the road.

BioGMP™ is the only product on the market for CGMP Training in biotechnology that has been designed from its inception to be an effective multimedia educational tool. Many well known biotechnology and pharmaceutical companies are using BioGMP™ to train their staff on the basics of CGMP compliance. BioGMP was developed in cooperation with Cambrex BioScience Corporation, a large Contract Manufacturing Organization, who has used the product to train their staff.

The product’s success can be shown through the diversity of its purchasers. Many large pharmaceutical and biotechnology companies in the United States, Europe and the Middle East have purchased BioGMPTM such as Acambis, Bayer Healthcare and Hoffmann-La Roche. This training package is not only useful to companies but many community colleges and universities have also purchased BioGMP™.

SPI USA’s services are managed by a SPI USA Senior Consultant and supported by SPI USA consultants and affiliated experts. SPI USA experts are selected from a personal network of proven independent consultants and well established professors from renowned academic programs with strong industry experience. SPI USA’s Core Consulting Team includes:

Antonio Moreira, Ph.D – amoreira@usaspi.com
Executive Vice President of SPI USA, Inc. and Vice Provost for Academic Affairs and Professor of Chemical and Biochemical Engineering at UMBC (University of Maryland, Baltimore County). Dr. Moreira spent nearly ten years in the private sector, with management positions both in the food industry with International Flavors and Fragrances, Inc. and in the pharmaceutical/biotechnology area with Schering-Plough Corporation. He has significant experience with R&D, scale-up and introduction to commercialization of biotechnology products, such as alpha interferon.

Mark Spinoglio – mspinoglio@usaspi.com
Senior Consultant with SPI USA – Irvine. Mr. Spinoglio manages project teams located in the United States, Europe and Asia on international assignments that assist companies in creating growth through product development, leveraging R&D, market expansions and business-to-business partnerships. As a consultant with SPI in Europe for a number of years, Mr. Spinoglio managed strategy development projects for the European Commission, which allowed him to establish a strong network of Science & Technology experts within Europe and other regions of the world.

Edward M. Sybert – esybert@usaspi.com
Senior Consultant for SPI USA, Inc. Mr. Sybert was recruited by the University of Maryland in 1984 to develop and direct a Biotechnology Program, aimed at assisting the growth of the biotechnology industry in the state. While at Maryland, he served as director of the Technology Advancement Program, a business incubation program for technology start-ups. With over thirty years experience in biotechnology and engineering, Mr. Sybert possesses invaluable experience in all aspects of bioprocessing and protein production. In addition to his University experience, Ed has consulted on a number of bio facility design projects, providing guidance on CGMP regulatory compliance, facility layout and equipment selection.

Elia D. Cossis – ecossis@usaspi.com
Consultant for SPI USA, Inc. Mr. Cossis has spent several years working for SPI in Europe and the United States. In this capacity, he has often taken the lead role in developing new projects and managing ongoing projects for private and public sectors on an international and national level. Mr. Cossis is a seasoned expert in the utilization of research methods and project management. He specializes in market and technology related studies that combine his in-depth understanding of the business and that draw upon his broad industry background.

Nicole Hawkins – nhawkins@usaspi.com
Project Manager with SPI USA, Inc. She provides support to senior consultants in areas such as CGMP compliance, process engineering, validation issues and GLP compliance. Nicole has also provided consultative support for numerous customized training programs. Nicole actively worked in conjunction with other SPI USA staff on the 2005 update to SPI USA, Inc.’s CD-ROM based training program the BioGMPTM.

To learn more about SPI USA, Inc.’s services and training programs please feel free to visit us at www.usaspi.com or contact SPI USA, Inc. at info@usaspi.com.