Streamlined Deviation Process Flows

PROJECT OVERVIEW

CAI assisted a leading cell and gene therapy company in New Jersey, USA, to improve their deviation management program and reduce product release time. The project involved a comprehensive assessment of the existing deviation process, followed by developing an innovative workflow to expedite low-level deviation resolution within 24 hours. CAI’s team conducted extensive training for over 600 personnel and implemented process improvements that resulted in a 73% reduction in overall cycle time for low-level deviations. This significant improvement helped the site meet its ambitious goals, streamlined resource allocation, and shifted focus to higher-impact patient safety solutions.

Topics Covered

• Deviation management process optimization
• Performance improvement in pharmaceutical manufacturing
• Cross-functional collaboration and stakeholder alignment
• Training and change management in regulated environments
• Process mapping and bottleneck identification
• Compliance enhancement in cell and gene therapy production
• Resource optimization and prioritization frameworks