Deliverables

• Business Diagnostic Review (Plan, Source, Make, Deliver, Enable) and process efficiency assessment with optimization plan

• Optimize Problem Solving Capabilities

• Implement Practical Process Improvement Principles

​

​

​

Deliverables

• cGMP de-risking:

  • Quality System

  • Facilities & Equipment

  • Materials

  • Production

  • Laboratory Controls

  • Package and Labeling

• Product + Process risk assessment

• Standard Work​​​​

​​​​​​​​​​​​​​

Deliverables

• System gap assessment + reconciliation plan

• Systems Roadmap

​

​

​​​​​

​

​

​

Deliverables

• EHS site facilities/process/system gap assessment + reconciliation plan

• Refresh EHS program transitioning from Reactive to Preventive

​

​

​