Commercial Functions: Managing Risk and Compliance Remediation of Multiple FDA-Certified Sites for Production of Sterilized Products

Situation

• The company had received poor inspection reports and warning letters from the authorities and needed to remediate multiple FDA-certified sites
• Genioo was asked to run a remediation program to mitigate the critical situation

Solution

• Genioo established a large cross-site, cross-functional remediation program with over 30 projects in eight workstreams focused on transparency and progress tracking
• The program ran over an 18 month period to fundamentally change processes, controls and employee behaviours focused on quality, closely managing culture change through all layers of a production site

Impact

• The remediation efforts led to great subsequent FDA inspection audits, where results showed great quality culture exhibited on site
• Key success factors included the rigorous tracking of KPIs supported by an active change culture leading to a greatly improved focus on quality laying out the fundament for further quality enhancements and a culture of continuous improvement of quality performance