James Petragnani
System Development Adviser - Petragnani Consulting, Inc. at Makro Technologies Inc.- Claim this Profile
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Bio
Experience
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Makro Technologies Inc.
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United States
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Staffing and Recruiting
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1 - 100 Employee
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System Development Adviser - Petragnani Consulting, Inc.
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Jun 2015 - Present
Developed web seminar to explain and illustrate the necessary requirements and steps required by the Federal Drug Administration (FDA) to implement Unique Device Identification (UDI). Presented and delivered the text to approximately 100 participants in the United States. Plans are in process to present to Europe and Asia. Developed web seminar to explain and illustrate the necessary requirements and steps required by the Federal Drug Administration (FDA) to implement Unique Device Identification (UDI). Presented and delivered the text to approximately 100 participants in the United States. Plans are in process to present to Europe and Asia.
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EY
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United Kingdom
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IT Services and IT Consulting
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700 & Above Employee
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Consultant Unique Device Identification (UDI) - Petragnani Consulting, Inc.
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Oct 2013 - Apr 2014
Developed a strategic plan for a large healthcare manufacture in the implementation of Unique Identification for medical devices in support of the FDA UDI (Unique Device Identification) Policy. • Identify global and business standard for product identification. • Review printed components (labels, instructions for use, operator manuals) against regulations. • Perform gap assessment • look for opportunities to simplify text, combine language, reduce components • Consider impact… Show more Developed a strategic plan for a large healthcare manufacture in the implementation of Unique Identification for medical devices in support of the FDA UDI (Unique Device Identification) Policy. • Identify global and business standard for product identification. • Review printed components (labels, instructions for use, operator manuals) against regulations. • Perform gap assessment • look for opportunities to simplify text, combine language, reduce components • Consider impact to other concurrent projects • Develop priorities for art changes for manufacturing and redress sites • Analyze impact on supply chain as a result of UDI Show less Developed a strategic plan for a large healthcare manufacture in the implementation of Unique Identification for medical devices in support of the FDA UDI (Unique Device Identification) Policy. • Identify global and business standard for product identification. • Review printed components (labels, instructions for use, operator manuals) against regulations. • Perform gap assessment • look for opportunities to simplify text, combine language, reduce components • Consider impact… Show more Developed a strategic plan for a large healthcare manufacture in the implementation of Unique Identification for medical devices in support of the FDA UDI (Unique Device Identification) Policy. • Identify global and business standard for product identification. • Review printed components (labels, instructions for use, operator manuals) against regulations. • Perform gap assessment • look for opportunities to simplify text, combine language, reduce components • Consider impact to other concurrent projects • Develop priorities for art changes for manufacturing and redress sites • Analyze impact on supply chain as a result of UDI Show less
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Trusted HandsServices
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Jacksonville, Florida Area
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Managing Principal Consultant - Petragnani Consulting, Inc.
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Dec 2011 - Sep 2013
Trusted Hand Services - Jacksonville, Florida Contact and collaborate with new and existing transportation and logistical clients and explore the opportunity to achieve higher supply chain excellence which can result in better business performance. Assist and work with these companies in the selection of technology to support their business objectives. Collaborate and work in tandem to fill the skill gap in the supply chain as it is prevalent within companies. Trusted Hand Services - Jacksonville, Florida Contact and collaborate with new and existing transportation and logistical clients and explore the opportunity to achieve higher supply chain excellence which can result in better business performance. Assist and work with these companies in the selection of technology to support their business objectives. Collaborate and work in tandem to fill the skill gap in the supply chain as it is prevalent within companies.
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Federal Drug Administration (FDA)
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Washington D.C. Metro Area
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Unique Device Identification (UDI) Consultant - Petragnani Consulting, Inc.
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Aug 2010 - Mar 2011
Unique Device Identification Initiative (UDI) - Support and advise members of the Healthcare Industry on the various approaches and solutions towards the implementation of identifying medical devices. Provide insight to the methodologies applied in the business world for products and devices. Work in tandem with the Healthcare Industry bringing forward the issues and challenges and assist in developing the strategy to support the identification and implementation of Unique Device… Show more Unique Device Identification Initiative (UDI) - Support and advise members of the Healthcare Industry on the various approaches and solutions towards the implementation of identifying medical devices. Provide insight to the methodologies applied in the business world for products and devices. Work in tandem with the Healthcare Industry bringing forward the issues and challenges and assist in developing the strategy to support the identification and implementation of Unique Device Identification (UDI). Show less Unique Device Identification Initiative (UDI) - Support and advise members of the Healthcare Industry on the various approaches and solutions towards the implementation of identifying medical devices. Provide insight to the methodologies applied in the business world for products and devices. Work in tandem with the Healthcare Industry bringing forward the issues and challenges and assist in developing the strategy to support the identification and implementation of Unique Device… Show more Unique Device Identification Initiative (UDI) - Support and advise members of the Healthcare Industry on the various approaches and solutions towards the implementation of identifying medical devices. Provide insight to the methodologies applied in the business world for products and devices. Work in tandem with the Healthcare Industry bringing forward the issues and challenges and assist in developing the strategy to support the identification and implementation of Unique Device Identification (UDI). Show less
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Department of Defense
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Washington D.C. Metro Area
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Program Manager - Petragnani Consulting, Inc.
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Feb 2009 - Jun 2010
Actively support the Office of the Secretary of Defense analyzing the various issues surrounding corrosion and provide a strategy to reduce corrosion cost of approximately $23 billion annually. Produce a productive strategy which will impact and reduce the annual budget. Manage project team work activities and interact with the various Military Service Executives. Identify all areas of deficiency which are causing additional cost. Evaluate present training requirements. Produce monthly… Show more Actively support the Office of the Secretary of Defense analyzing the various issues surrounding corrosion and provide a strategy to reduce corrosion cost of approximately $23 billion annually. Produce a productive strategy which will impact and reduce the annual budget. Manage project team work activities and interact with the various Military Service Executives. Identify all areas of deficiency which are causing additional cost. Evaluate present training requirements. Produce monthly status report on project activity. Interact with various military agencies and executives. Show less Actively support the Office of the Secretary of Defense analyzing the various issues surrounding corrosion and provide a strategy to reduce corrosion cost of approximately $23 billion annually. Produce a productive strategy which will impact and reduce the annual budget. Manage project team work activities and interact with the various Military Service Executives. Identify all areas of deficiency which are causing additional cost. Evaluate present training requirements. Produce monthly… Show more Actively support the Office of the Secretary of Defense analyzing the various issues surrounding corrosion and provide a strategy to reduce corrosion cost of approximately $23 billion annually. Produce a productive strategy which will impact and reduce the annual budget. Manage project team work activities and interact with the various Military Service Executives. Identify all areas of deficiency which are causing additional cost. Evaluate present training requirements. Produce monthly status report on project activity. Interact with various military agencies and executives. Show less
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GS1 US
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United States
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Non-profit Organizations
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100 - 200 Employee
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Director, Business Development
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Jan 1999 - Dec 2008
International trade organization/global supply chain standards body that invented the U.P.C. bar code and manages the global bar code system used by 25 industries to facilitate commerce in 140 nations. Director, Business Development Responsible for expanding the use of global GS1 supply chain standards for physical identification and electronic commerce in the public, industrial and manufacturing sectors. Worked with members of the Department of Defense and Aviation Industry to… Show more International trade organization/global supply chain standards body that invented the U.P.C. bar code and manages the global bar code system used by 25 industries to facilitate commerce in 140 nations. Director, Business Development Responsible for expanding the use of global GS1 supply chain standards for physical identification and electronic commerce in the public, industrial and manufacturing sectors. Worked with members of the Department of Defense and Aviation Industry to define and establish Unique Identification (UID) Standards to support the identification of Asset Identification. Developed strategic plan for re-establishing the organization's working relationship with the U.S. Department of Defense and other key agencies to encourage multi-agency endorsement and improve government's security and supply chain management processes. Jointly worked with U.S. Customs and Border Protection to identify small arms weapons, armor and credentials for all Border Patrol agents. Collaborated with Department of Homeland Security with the use of Radio Frequency Identification (RFID) to identify small arms weapons for airline pilots and air marshals. Worked in conjunction with Homeland Security and government contractors supporting the effort to safeguard the border in the Southwest using a virtual fence. Worked with Transportation Security Administration in their efforts to implement critical airport security equipment (scanners, cameras, small arms weapons) in over 400 airports. Actively worked with NATO Nations in efforts to safeguard shipments on sea vessels, air transports and land carriers. Show less International trade organization/global supply chain standards body that invented the U.P.C. bar code and manages the global bar code system used by 25 industries to facilitate commerce in 140 nations. Director, Business Development Responsible for expanding the use of global GS1 supply chain standards for physical identification and electronic commerce in the public, industrial and manufacturing sectors. Worked with members of the Department of Defense and Aviation Industry to… Show more International trade organization/global supply chain standards body that invented the U.P.C. bar code and manages the global bar code system used by 25 industries to facilitate commerce in 140 nations. Director, Business Development Responsible for expanding the use of global GS1 supply chain standards for physical identification and electronic commerce in the public, industrial and manufacturing sectors. Worked with members of the Department of Defense and Aviation Industry to define and establish Unique Identification (UID) Standards to support the identification of Asset Identification. Developed strategic plan for re-establishing the organization's working relationship with the U.S. Department of Defense and other key agencies to encourage multi-agency endorsement and improve government's security and supply chain management processes. Jointly worked with U.S. Customs and Border Protection to identify small arms weapons, armor and credentials for all Border Patrol agents. Collaborated with Department of Homeland Security with the use of Radio Frequency Identification (RFID) to identify small arms weapons for airline pilots and air marshals. Worked in conjunction with Homeland Security and government contractors supporting the effort to safeguard the border in the Southwest using a virtual fence. Worked with Transportation Security Administration in their efforts to implement critical airport security equipment (scanners, cameras, small arms weapons) in over 400 airports. Actively worked with NATO Nations in efforts to safeguard shipments on sea vessels, air transports and land carriers. Show less
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GS1 Global Office (formerly EAN International)
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Brussels Area, Belgium
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Consultant
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1998 - 2008
Supported the GS1 International Global Office developing and implementing the GS1 Standard and enhancing the business and logistic processes within the supply chain of various government agencies. The majority of this effort was concentrated in providing logistical and supply chain support to NATO and it's alliance countries. Worked predominately with the Global Customs Logistics Project which emphasized the security of sea shipping containers and it's content. Utilized Radio Frequency… Show more Supported the GS1 International Global Office developing and implementing the GS1 Standard and enhancing the business and logistic processes within the supply chain of various government agencies. The majority of this effort was concentrated in providing logistical and supply chain support to NATO and it's alliance countries. Worked predominately with the Global Customs Logistics Project which emphasized the security of sea shipping containers and it's content. Utilized Radio Frequency Identification (RFID) as they technical solution for this project. Show less Supported the GS1 International Global Office developing and implementing the GS1 Standard and enhancing the business and logistic processes within the supply chain of various government agencies. The majority of this effort was concentrated in providing logistical and supply chain support to NATO and it's alliance countries. Worked predominately with the Global Customs Logistics Project which emphasized the security of sea shipping containers and it's content. Utilized Radio Frequency… Show more Supported the GS1 International Global Office developing and implementing the GS1 Standard and enhancing the business and logistic processes within the supply chain of various government agencies. The majority of this effort was concentrated in providing logistical and supply chain support to NATO and it's alliance countries. Worked predominately with the Global Customs Logistics Project which emphasized the security of sea shipping containers and it's content. Utilized Radio Frequency Identification (RFID) as they technical solution for this project. Show less
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Director, Information Technology and Supply Chain
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Jan 1998 - Jan 1999
A $1.5 billion manufacturer and distributor of food products. Director, Information Technology & Supply Chain Applications Responsible for all Information Technology at company's world headquarters. Managed an IT staff of 20 and a $5 million IT software budget. Member of the company's North American Steering Committee, with direct responsibility for IT policy, standard-setting and architecture design. Developed all necessary technology solutions to improve the company's… Show more A $1.5 billion manufacturer and distributor of food products. Director, Information Technology & Supply Chain Applications Responsible for all Information Technology at company's world headquarters. Managed an IT staff of 20 and a $5 million IT software budget. Member of the company's North American Steering Committee, with direct responsibility for IT policy, standard-setting and architecture design. Developed all necessary technology solutions to improve the company's sales, manufacturing, logistics and electronic commerce activities. Implemented Enterprise Resource Planning (ERP) solution for company's entire North American operations, including four manufacturing plants and 12 supplier farms. Created and implemented newly-established IT procedures for security, Help Desk and Application Change Management Guidelines. Show less A $1.5 billion manufacturer and distributor of food products. Director, Information Technology & Supply Chain Applications Responsible for all Information Technology at company's world headquarters. Managed an IT staff of 20 and a $5 million IT software budget. Member of the company's North American Steering Committee, with direct responsibility for IT policy, standard-setting and architecture design. Developed all necessary technology solutions to improve the company's… Show more A $1.5 billion manufacturer and distributor of food products. Director, Information Technology & Supply Chain Applications Responsible for all Information Technology at company's world headquarters. Managed an IT staff of 20 and a $5 million IT software budget. Member of the company's North American Steering Committee, with direct responsibility for IT policy, standard-setting and architecture design. Developed all necessary technology solutions to improve the company's sales, manufacturing, logistics and electronic commerce activities. Implemented Enterprise Resource Planning (ERP) solution for company's entire North American operations, including four manufacturing plants and 12 supplier farms. Created and implemented newly-established IT procedures for security, Help Desk and Application Change Management Guidelines. Show less
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Director, E-Commerce
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Jan 1991 - Jan 1998
An $8 billion marketer and distributor of fine paper and industrial products. Director of Electronic Commerce Responsible for developing and implementing the company's strategic and tactical Electronic Commerce plan (including Electronic Data Interchange and bar coding) to achieve improvements in operational efficiencies. Initiatives enabled company to generate additional $2 million annually in top line revenue. Communicated company's Electronic Commerce strategy and technical… Show more An $8 billion marketer and distributor of fine paper and industrial products. Director of Electronic Commerce Responsible for developing and implementing the company's strategic and tactical Electronic Commerce plan (including Electronic Data Interchange and bar coding) to achieve improvements in operational efficiencies. Initiatives enabled company to generate additional $2 million annually in top line revenue. Communicated company's Electronic Commerce strategy and technical requirements to trading partners to ensure smooth integration and compliance. Implemented Radio Frequency Identification technology into warehouse systems to improve receiving and order fulfillment. Developed and installed new systems and solutions to improve inventory management and order tracking. Directed the technology migration and integration of several major company acquisitions into a common hardware/software platform, consistently delivering these initiatives under budget. Show less An $8 billion marketer and distributor of fine paper and industrial products. Director of Electronic Commerce Responsible for developing and implementing the company's strategic and tactical Electronic Commerce plan (including Electronic Data Interchange and bar coding) to achieve improvements in operational efficiencies. Initiatives enabled company to generate additional $2 million annually in top line revenue. Communicated company's Electronic Commerce strategy and technical… Show more An $8 billion marketer and distributor of fine paper and industrial products. Director of Electronic Commerce Responsible for developing and implementing the company's strategic and tactical Electronic Commerce plan (including Electronic Data Interchange and bar coding) to achieve improvements in operational efficiencies. Initiatives enabled company to generate additional $2 million annually in top line revenue. Communicated company's Electronic Commerce strategy and technical requirements to trading partners to ensure smooth integration and compliance. Implemented Radio Frequency Identification technology into warehouse systems to improve receiving and order fulfillment. Developed and installed new systems and solutions to improve inventory management and order tracking. Directed the technology migration and integration of several major company acquisitions into a common hardware/software platform, consistently delivering these initiatives under budget. Show less
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Subaru of America
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United States
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Motor Vehicle Manufacturing
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700 & Above Employee
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Manager Applications
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Jan 1982 - Jan 1991
U.S. headquarters of a leading Japanese automobile company. Manager of Applications Planned and implemented a Vehicle Distribution and Information System that improved delivery of vehicles to 850 North American dealers. Recommended and implemented new financial systems technologies to improve activities in the Finance and Accounting groups. Reorganized and centralize the corporate regions, reducing administrative burden, increasing savings and improving customer satisfaction… Show more U.S. headquarters of a leading Japanese automobile company. Manager of Applications Planned and implemented a Vehicle Distribution and Information System that improved delivery of vehicles to 850 North American dealers. Recommended and implemented new financial systems technologies to improve activities in the Finance and Accounting groups. Reorganized and centralize the corporate regions, reducing administrative burden, increasing savings and improving customer satisfaction. Helped company achieve $1.2 million in cost savings. Show less U.S. headquarters of a leading Japanese automobile company. Manager of Applications Planned and implemented a Vehicle Distribution and Information System that improved delivery of vehicles to 850 North American dealers. Recommended and implemented new financial systems technologies to improve activities in the Finance and Accounting groups. Reorganized and centralize the corporate regions, reducing administrative burden, increasing savings and improving customer satisfaction… Show more U.S. headquarters of a leading Japanese automobile company. Manager of Applications Planned and implemented a Vehicle Distribution and Information System that improved delivery of vehicles to 850 North American dealers. Recommended and implemented new financial systems technologies to improve activities in the Finance and Accounting groups. Reorganized and centralize the corporate regions, reducing administrative burden, increasing savings and improving customer satisfaction. Helped company achieve $1.2 million in cost savings. Show less
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Education
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University of Wisconsin-Madison
Certificate, Electronic Commerce -
Marshall University
Bachelor of Business Administration (B.B.A.), Accounting and Business/Management