Operational Improvements: Integrated Solutions

PROJECT OVERVIEW

A biotech manufacturing company, preparing for the launch of its first batches of a new drug, identified the need to implement performance measurement even before commercial manufacturing was begun. The global CAI project team had the expertise to help the drug manufacturing client, not only understand what KPIs should be monitored, but also provide a method for converting identified KPIs into a two-level dashboard to display, analyze, review, and monitor the results, against site objectives. The project team worked with each department to identify current KPIs, assess any gaps, and recommend additional KPIs. Based on these KPI, dashboards were developed to present at both the site and departmental levels.

Topics Covered

• Data analysis and trending for process improvement
• GMP coaching and training for manufacturing personnel
• Quality assurance in pharmaceutical manufacturing
• Continuous improvement program implementation
• Batch record review process optimization
• Error rate reduction strategies
• Change management in regulated environments