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2019 Human Performance, Root Cause, & Trending (HPRCT) Conference
June 17-21, 2019
Cheyenne Mountain Resort
Colorado Springs, Colorado
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Tuesday, June 18 • 3:00pm - 3:50pm
Shifting the Model of Performing Investigations in Biotechnology: The Biogen Story

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The purpose of this talk will be to describe Biogen’s journey of integrating Human Performance principles into the investigation process in the biotechnology industry; from initially walking in the footsteps of the “Old View,” to blazing a new path based on the “New View.” This presentation will describe the path taken by Biogen starting in 2015 with an overemphasis on “human error” to a systematic approach in investigations. Advancing to a systematic approach led to identifying causes at the organizational level as opposed to only uncovering causes at the local level. In addition to the above, organizational analysis presented challenges to the biotech industry, which led to confusion about the application of Human Performance principles into the investigation process. The state of investigations at Biogen in 2019 is quite different from 2015. The integration of the systems approach, use of multi-causal causal analysis methods, delineation of local and organizational factors, evaluation of extent of condition and cause, and learning teams have defined excellence in investigations and established a framework for resilience.

Speakers
avatar for Natalie

Natalie

Manager of Investigations, Biogen
Natalie Upchurch Manager, Investigations, Performance & Process Improvement Biogen, North American Region.  Natalie’s role as a Manager of the Investigations Team is inclusive of Biogen’s RTP Drug Substance and Drug Product site operations. Natalie and staff are pioneers of implementing... Read More →
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Ellery Ward

Investigator l, Biogen
Ellery Ward Investigator I, Investigations Performance and Process Improvement Biogen, North American Region Ellery Ward is currently an Investigator at Biogen. She graduated from North Carolina State University in 2013 with a B.S. in Chemical Engineering and a concentration in Biomanufacturing... Read More →


Tuesday June 18, 2019 3:00pm - 3:50pm MDT
Cheyenne ll

Attendees (5)