Design of Critical Utilities for Biomanufacturing Facilities

NEXT CERTIFICATE PROGRAM SEPTEMBER 9-12, 2014. April 21-24, 2015.  October 13-16, 2015.

The construction and renovation of biomanufacturing facilities requires an understanding of how biomanufacturing processes need to operate within a facility and within the code and regulations set by the FDA. These include understanding process flow, safety regulations and clean utility requirements to ensure an economic and compliant design and appropriately installed utilities.

Construction firms, contractors and design architects wishing to be more successful with their biomanufacturing projects, or those wishing to begin servicing this industry, need to understand the critical regulations governing this industry, and how those regulations may impact the design and construction of utility systems in these facilities.

Key Learning Objectives

  • Biomanufacturing utility sytem design considerations
  • The role of Quality by Design (ICH Q8) in facility design
  • Regulatory expectations - Designing for Compliance
  • Defining the process - CQAs, CPPs, Design Space
  • Equipment and facility considerations
  • “Clean” Utility and Support systems
  • Facility and utility system qualification
  • Risk Assessment (ICH Q9)
  • Project Delivery platform impact

Benefits of this training

  • Increased utilization and better control of utility system excursions
  • Learn practical considerations for maintenance, operation and troubleshooting
  • Improve design choices by understanding factors impacting biomanufacturing facility design and compliance with GMP and FDA regulations
  • Improve ROI through preventative practices 
  • Develop a solid reputation for the design, construction and commissioning of biomanufacturing facilities

WPI is the only education provider to offer this comprehensive overview of what is needed to design and build biomanufacturing facilities - other training programs only scratch the surface of what you need to know. Class size is limited to 35 - reserve your seat early.

Program Logistics


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Who should attend

  • Biomanufacturing facility maintenance, metrology and engineering personnel
  • Construction companies, contractors and architectural design firms involved with serving the industry
  • Facility engineers, facility designers, and mechanical engineers employed or about to be employed in the building of biomanufacturing facilities
  • Quality control microbiology technicians involved in environmental monitoring
  • Quality assurance personnel responsible for the review of maintenance logs, change control documentation and CAPAs