This guideline highlights the importance of CAPA systems in pharmaceutical and medical device manufacturing to ensure regulatory compliance and product safety. It explains how CAPA
This document outlines a stability program to ensure drug product quality over time. It covers method validation, protocol development, shelf-life determination, and ongoing monitoring, following
A major medical device company faced a recidivist FDA warning letter due to repeated quality system issues and engaged QualityHub for comprehensive audits and remediation
A leading medical device manufacturer faced costly penalties from an unresolved FDA consent decree due to unaddressed product issues across 50 failure modes. QualityHub’s comprehensive
A leading cardiovascular company faced significant quality system failures and FDA compliance challenges due to inadequate infrastructure and leadership gaps. QualityHub provided interim expert staffing,
A global biotechnology leader partnered with QualityHub to conduct thorough third-party audits across its facilities, suppliers, and R&D sites, ensuring rigorous compliance and risk management.
QualityHub partnered with a global pharmaceutical and medical device company to transform a reactive CAPA system into a proactive, cross-functional process aligned with FDA expectations.
A global cardiovascular health company facing severe FDA compliance issues, including a corporate warning letter and multiple recalls, partnered with QualityHub to address urgent regulatory
Faced with a massive backlog of 30,000 complaint records and limited internal resources, a leading In-Vitro Diagnostics company partnered with QualityHub to regain compliance under
Despite the long run up to preparations, it can still feel like you’re not prepared for EU MDR compliance. With the new MDR deadline rapidly