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Submitted URL: http://trk.klclick.com/ls/click?upn=FUTsgvct74b8qBjqYFazLo6KI5nyFFEpV6xdgvxIgJegRNe-2ByU8RKzVRJZEOpfHQ5khvBRS2KDQpUcert...
Effective URL: https://kenx.org/kenx_insights/high-stakes-change-management-remediation-post-fda-warning-letter/?utm_source=Full...
Submission: On February 03 via manual from HK — Scanned from DE

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              <p style="text-align: center;"><strong style="font-size: 24px;">DON'T MISS OUT!</strong></p>
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HIGH STAKES CHANGE MANAGEMENT:
REMEDIATION POST FDA WARNING LETTER







ABSTRACT



Your company has received an FDA warning letter, now what? As an organization
finds itself in uncharted waters due to inspection results, the leader’s job is
to chart a course and speed to re-inspection success without everyone jumping
ship. Leaders must remember historical averages for change success hovers
between 30-50% (Adam & Danaparamita, 2016; Beer et al., 1990; Kotter, 1995)
during normal operations, let alone high stakes environments. Abnormal operating
conditions decreases colleagues’ cognitive processing ability and result in
behavioral decision making. This combination is dangerous in ambiguous operating
environments with underdeveloped cultures. The organization takes social cues
from leadership, which influence colleague attitudes based on responsibility and
accountability. Leadership’s ability to control stress in the organization
preserves resources by reducing tension, providing clarity, making trade-off
decisions, and fostering effective two-way communication. Developed leaders know
these attributes preserves resources, sustains culture, and leads organizations
through high stakes change management environments.

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Chris Gray

Principal Consultant, CAI     

--------------------------------------------------------------------------------

Chris currently serves as a Principal Consultant for CAI, Inc where he provides
biopharmaceutical clients with guidance on Organizational and Human
Performance. In his past, Chris has led functional elements and multi-site
organizations in pharmaceutical, beverage, and the plastics industries. He is a
Lean Six Sigma Black Belt, Associate Certified Coach, and currently pursuing his
PhD in Industrial and Organizational Psychology from Northcentral University.  

 





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