Organizational Learning

PROJECT OVERVIEW

CAI assisted a manufacturer of a promising new therapy in preparing for FDA approval. The company faced significant challenges, including recent executive leadership changes and a tight one-year timeline to demonstrate control before the pre-approval inspection. CAI implemented a focused organizational learning approach to help site leadership develop sustainable control processes across Operations, Training & Qualification, Quality, and Supply Chain departments. By setting clear directions with understandable metrics, CAI addressed morale and turnover issues while facilitating improvement programs across multiple critical functions. This integrated approach enabled leaders and staff to visualize and achieve successful outcomes within the accelerated timeline.

Topics Covered

• Preparation for FDA approval in pharmaceutical manufacturing
• Organizational learning and process improvement
• Cross-functional leadership development
• Employee engagement and morale improvement
• Quality control and assurance in regulated environments
• Change management during executive transitions
• Accelerated timeline management for regulatory compliance