Project Experience includes:

· Site Validation (CSV, Equipment and Process)

· Digital Printing Press Validation

· Development and Implementation of site validation strategy for automation

· Implementation of a Site Validation Process

· Implementation of an Asset Life Cycle process

· Validation of Vision System

· Validation of MES LIMS and Data Historian and integration with ERP

· Implementation of Asset Lifecycle Process

· Definition and Implementation of Electronic Process Control

· Validation of ERP Systems —MFG/Pro, Navasion, Bann, SAP

· IMB and FDA Audit Preparation

· EDMS Validation

· ERP selection and vendor auditing

· Supplier Auditing

· Internal Auditing

· Definition and Design Of a CAPA and Event Management system

· Part 11 Remediation

· Integration of SAP and a EDMS

· Systems Definition and Design