DME Facility Focus 1: Flexibility by Design: GMP Manufacturing for the Diverse Product Portfolio

DME Facility Focus 1: Flexibility by Design: GMP Manufacturing for the Diverse Product Portfolio

04/18/2018, 10:30 AM - 11:30 AM

Technical Conference Stage 1, Booth 1076, Exhibit Hall


GMP facilities are increasingly challenged to accommodate production diversity, adapt to evolving business needs, and deliver high quality products with low cost of goods. Broadly speaking, we need flexible facilities that allow us to take advantage of opportunities, mitigate risk, and support high utilization. Yet GMP facilities are often flex-challenged because traditional approaches to facility-based segregation for product protection have driven less flexibility. How can the facility planning and design process accommodate the diverse business needs of modern manufacturing while delivering robust and compliant facilities? DME Facility Focus has surveyed cGMP manufacturers nationwide and assembled a panel of experts to answer that question. Join our dialog on current trends, tools and tactics to design flexible facilities that are agile, versatile, and efficient.


  • David Marks, PE


    President and Principal Consultant


    David M. Marks is the principal and founder of DME, an engineering firm that specializes in providing solutions for advanced technology facilities. ...

Type of Session

  1. Type of Session

Learning Objectives

  1. Learning Objectives • Learn how other manufacturers prioritize flexibility requirements 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 technologies that can facilitate flexibility – such as modularity, process closure, single use, and continuous manufacturing. • Learn how industry leaders are approaching the regulatory questions regarding facility flexibility. • Develop an understanding of priorities and perspectives from across the industry.

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