GxP Engagement: CMO Inspection Readiness
The Project.
CMO Inspection Readiness
The Case.
Represent Owner on-site at CMO to ensure compliant manufacture of the product and robust QMS for inspection readiness.
The Solution.
Project Team Deployed:
- 1 x Project Manager
- 4 x SME Consultants
The Outcome.
Successful Gap Analysis led to prioritized action plan that focused on lab events, deviation management and workflow.
i-Pharm GxP's team ensured ensured we had the robust processes in place required for a successful inspection.
Find out more
Featured Case Studies
03/07/2023
Case Study: Global VP Regulatory Affairs, Australian Medical Devices Company
A Mid-Sized Australian Medical Devices R&D Company had a requirement for a Global VP of Regulatory Affairs.
Read more
03/07/2023
GxP Engagement: QC Investigations for Microbiology Lab
QC Investigations for Microbiology Lab
Read more
20/06/2023
GxP Engagement: Interim Leadership for growing Biotech
Senior Level Interim Leadership
Read more
