Benjamin Frey

Biography

 Benjamin Frey is the Senior Director of Quality Systems, and is responsible for technical support and Subject Matter Expertise for the company’s Quality Assurance and Regulatory Compliance projects in compounding pharmacy, pharmaceutical, biotechnology, medical device / IVD and dietary supplement product markets for human and veterinary use.  Benjamin brings approximately 25 years of experience working within a broad range of FDA regulated environments, and all responsibilities have been performed within compliance of GMP requirements and quality management programs and include Quality Assurance, Validation, and Quality Control functions.  His broad range of practical and risk-based experience includes quality system development and management, Quality Assurance, quality auditing and gap remediation, project management, laboratory operations, environmental monitoring program development, cleaning validation, equipment and utilities validation and process validation.  Benjamin’s most recent expertise is to utilize risk management tools to develop and manage Quality System for compounding pharmacies registering as 503B facility and transitioning system from USP <797> to GMP compliance.  He has also recently provided Quality System development and management support for hospital aseptic compounding facilities.  His management and hands-on technical experience provides creative, practical and compliant solutions for customer quality and compliance projects. Benjamin has a B.S. in Systematic Biology from the University of Kansas and an M.S. in Biology from Emporia State University.  He has presented public seminars and workshops in areas of 503B outsourcing facility regulatory compliance, Quality Systems and GMP compliance, cleaning validation, environmental monitoring and utility systems validation.

Research Interest

 Benjamin Frey is the Senior Director of Quality Systems, and is responsible for technical support and Subject Matter Expertise for the company’s Quality Assurance and Regulatory Compliance projects in compounding pharmacy, pharmaceutical, biotechnology, medical device / IVD and dietary supplement product markets for human and veterinary use.  Benjamin brings approximately 25 years of experience working within a broad range of FDA regulated environments, and all responsibilities have been performed within compliance of GMP requirements and quality management programs and include Quality Assurance, Validation, and Quality Control functions.  His broad range of practical and risk-based experience includes quality system development and management, Quality Assurance, quality auditing and gap remediation, project management, laboratory operations, environmental monitoring program development, cleaning validation, equipment and utilities validation and process validation.  Benjamin’s most recent expertise is to utilize risk management tools to develop and manage Quality System for compounding pharmacies registering as 503B facility and transitioning system from USP <797> to GMP compliance.  He has also recently provided Quality System development and management support for hospital aseptic compounding facilities.  His management and hands-on technical experience provides creative, practical and compliant solutions for customer quality and compliance projects. Benjamin has a B.S. in Systematic Biology from the University of Kansas and an M.S. in Biology from Emporia State University.  He has presented public seminars and workshops in areas of 503B outsourcing facility regulatory compliance, Quality Systems and GMP compliance, cleaning validation, environmental monitoring and utility systems validation.