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Facility Focus

O’Neal/DME Facility Focus—It’s Time For Dialog

New Challenges Require a Different Mindset

O’Neal/DME is looking ahead to our 4th Annual Facility Focus program at INTERPHEX 2019. From its beginning, Facility Focus was designed to create a dialog within the industry regarding how we are going to meet the new challenges for practical facility designs.

For 2019, O’Neal/DME will be hosting two programs:

  •  Single Use BioManufacturing: Designing the Facility of the Future will be held on Wednesday, April 3, 10:00-10:45. David Marks, Moderator

    Last year’s Facility Focus survey identified Single Use as the single most useful technology to improve facility flexibility, manufacturing efficiency and utilization.   This year we will be taking a deep dive into the impact of single-use systems on the design and delivery of biomanufacturing facilities.  Regardless of whether you are renovating existing GMP space or developing a new facility for single use processing, the choice of process technology has profound implications for space programming, layout, cleanroom classification, utilities, and material handling.  Every aspect of project delivery – from initial planning to final commissioning and qualification – is influenced by the degree of single-use implementation.  Join our panel on industry experts to discuss the results of our latest nationwide survey of GMP manufacturers and better understand how future facilities can best leverage the benefits of single-use technology.

    Learning Objectives:      

Learn how other manufacturers implement single-use technology in new and legacy facilities.

Gain a better understanding of the trends shaping our industry; what’s driving change; how competitors are responding; and how others are turning problems into opportunities.

Enhance your understanding of the impact of single-use technology on project delivery.

Learn how industry leaders are approaching the regulatory questions associated with single-use technology.

Develop an understanding of priorities and perspectives from across the industry.


  • Priming Projects for Success: Planning and Capital Appropriation for GMP Facilities will be held on Wednesday, April 3, 1:15-2:00.  Jeff Hall, Moderator

Managing capital projects in complex facilities requires both accurate risk assessment and careful planning.  Using lessons learned from years of project experience in GMP facilities, our panel discussion will explore strategies to ensure that capital projects are staged with the greatest probability of success.  Project organization, scope definition, risk assessment, appropriate pricing and scheduling are all critical components of front end planning that contribute to the success or failure of a project.  Join the discussion as we evaluate the results of our latest nationwide survey of GMP project professionals.

Learning Objectives:      

Learn how GMP manufacturers typically approach capital appropriation and project planning.

Gain a better understanding of the unique challenges and risks associated with GMP capital projects and how to mitigate them through front-end planning and preparation.

Explore best practices and tools, such as the new PDRIx risk assessment and project readiness tool for manufacturing and life sciences projects.

Enhance your understanding of how the latest advancement in technologies for project execution, such as earned value reporting and BIM, can be leveraged to improve project outcomes.

Our sessions will be built around data received from our industry wide surveys. 

What does Facility Focus provide for INTERPHEX Attendees?

  • A better understanding of the trends shaping our industry, what’s driving change, how competitors are responding and how others are turning problems into opportunities
  • Advice on how to approach the regulatory questions regarding compliance facilities and producing safer, higher quality products
  • An understanding of priorities across the industry—from manufacturers, regulatory authorizes, academia, and service providers


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