How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach
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 Group'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.
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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...
Free Webinar: Effective FDA Engagement
FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...