DeSantis Consulting Associates
Consulting practice focused on pharmaceutical engineering and GMP compliance. Services include GMP-focused project management for capital projects, quality systems and compliance consulting, facilities and equipment engineering, process validation and sterilization expertise, and customized professional training for pharmaceutical and biotech organizations. Founder has >40 years industry experience and prior senior engineering/compliance roles.
Industries
Nr. of Employees
small (1-50)
DeSantis Consulting Associates
Reynoldsburg, Ohio, United States
Products
Project Roadmap
A proprietary GMP project management solution.
The Project Roadmap: A comprehensive and highly effective approach to managing GMP capital projects
Customizable professional development and GMP training course covering a comprehensive and effective approach to managing GMP capital projects.
Facilities and Equipment
Pharmaceutical engineering firm providing GMP consulting services for facilities and equipment.
GMP Project Management
A unique GMP project management solution that integrates the proven concepts of front-end loading and stage-gating with GMP requirements to provide an effective capital management process.
Process Validation Today
Professional development and GMP training offering developed in partnership with Agalloco & Associates.
Good Engineering Practices in the GMP Environment
Customizable professional development and GMP training course focused on good engineering practices within the GMP environment.
Project Roadmap
A proprietary GMP project management solution.
The Project Roadmap: A comprehensive and highly effective approach to managing GMP capital projects
Customizable professional development and GMP training course covering a comprehensive and effective approach to managing GMP capital projects.
Facilities and Equipment
Pharmaceutical engineering firm providing GMP consulting services for facilities and equipment.
GMP Project Management
A unique GMP project management solution that integrates the proven concepts of front-end loading and stage-gating with GMP requirements to provide an effective capital management process.
Process Validation Today
Professional development and GMP training offering developed in partnership with Agalloco & Associates.
Good Engineering Practices in the GMP Environment
Customizable professional development and GMP training course focused on good engineering practices within the GMP environment.
Services
Consulting focused on GMP compliance across quality systems, facilities, equipment and project execution for pharmaceutical and biotech clients.
Implementation of a scalable GMP project management roadmap for capital projects that integrates FEL and stage-gating and includes project controls and team-development guidance.
Advisory services on design, operation, standards and qualification for facilities, equipment and critical utilities.
Customized training courses on HVAC systems, high-purity water systems, good engineering practices, process validation, sterilization and aseptic processing.
Consulting focused on GMP compliance across quality systems, facilities, equipment and project execution for pharmaceutical and biotech clients.
Implementation of a scalable GMP project management roadmap for capital projects that integrates FEL and stage-gating and includes project controls and team-development guidance.
Advisory services on design, operation, standards and qualification for facilities, equipment and critical utilities.
Customized training courses on HVAC systems, high-purity water systems, good engineering practices, process validation, sterilization and aseptic processing.
Expertise Areas
- GMP consulting and compliance
- GMP project management for capital projects
- Quality systems and Quality Risk Management
- Facilities and equipment engineering
Key Technologies
- GMP project lifecycle roadmapping (front-end loading and stage-gating)
- Process validation methodologies
- Sterilization methods (steam and dry heat)
- Aseptic processing techniques
News & Updates
Blog post introducing the site and the author's background in pharmaceutical manufacturing, quality operations and validation (April 21, 2014).
Blog post discussing causes and impacts of drug shortages, with emphasis on quality-related manufacturing problems and sterile product vulnerabilities (November 26, 2014).
First podcast episode in which the founder discusses the current state of the pharmaceutical and biotech industry (January 21, 2014).
Blog post introducing the site and the author's background in pharmaceutical manufacturing, quality operations and validation (April 21, 2014).
Blog post discussing causes and impacts of drug shortages, with emphasis on quality-related manufacturing problems and sterile product vulnerabilities (November 26, 2014).
First podcast episode in which the founder discusses the current state of the pharmaceutical and biotech industry (January 21, 2014).