Investigation Effectiveness Drives Human Performance Excellence
Are investigations supporting or hindering performance excellence?
Every biopharm company conducts investigations for undesirable outcomes related to safety, quality, and reliability of product and processes. The question is to what degree do these investigations support or hinder performance excellence?
A sub-team that was formed as part of the BioPhorum Operations Group (BPOG) human performance workstream sought to answer this question. The findings suggest that biopharm is behind other industries with respect to investigation best practices.
This article provides a pathway for the industry to improve its investigations, and in so doing, improve overall organizational learning and performance.
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Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
