Contact Information

Biography

Mr. Falcione is a seasoned corporate executive with extensive industry experience in quality management and regulatory affairs.  He has held senior executive positions at ChemImage (Director, Quality and Regulatory Affairs), where he was responsible for defining Quality and Regulatory strategies; ALung Technologies (Senior Vice President, Regulatory Affairs and Quality Assurance), where he led business process improvements, gap analysis and remediation activities in the areas of product development, quality systems, supply chain/supplier management, regulatory compliance and manufacturing; CHS Business Associates (Vice President Technologies), where he led regulatory activities and quality improvement processes for client companies; and Emerson (Director of Strategic Quality) where his responsibilities included the development, direction, and management of quality/engineering systems and product integrity and reliability test engineering.  Prior to Emerson, Mr. Falcione held senior positions at Chiron Diagnostics and Ferranti Defense Systems, Inc.

Education

  • B.S. in Electronics Engineering,  Pennsylvania State University
  • E.M.B.A. in Business, Baldwin-Wallace College.

Research Interests or Expertise

  • Product Integrity and Reliability
  • Test Engineering
  • Quality Systems: development, implementation, and maintenance
  • FDA regulatory review and approval

 

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  • BTGY 504 Regulatory Aspects of the Development of Medical Products
  • BTGY 508 Biotechnology
  • BTGY 509 Biotechnology Product Development