How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach

How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach Image

A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation commitments by addressing their overdue backlog of deviations and investigations. As a result of an agreement with the FDA, the company was under a pressured time constraint to reduce the backlog and put the program into a sustainable management state.

Find out how ProPharma's team of experts successfully and rapidly implemented project management methodologies to properly manage the deviation and investigation systems and provided hands-on support for backlog reduction.

Case Study

Share

Infographic Infographic

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Infographic

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Infographic

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...