Global Serialization Program Management
Industry
Pharmaceuticals
Project
Global Serialization Program Management
Client
Highly focused generics and specialty pharmaceutical company.
Objective
Support DSCSA compliance and enable CMO serialization readiness for four packaging sites and the distribution center.
Approach
- Packaging line integration and validation for L1, L2 and L3 additions
L4/5 Integration and validation to all packaging site
- Onboarding and validation of all CMO’s
- Onboarding and validation of all CMO’s
Added Value
- Provided the necessary PM’s to lead and drive the three components of the serialization program
- Provided the SME’s in the validation, engineering and compliance areas
- Provided the SME’s in the validation, engineering and compliance areas
