Challenge: Lacking infrastructure leads to consent decree complications

A leading cardiovascular company (henceforth known as the Client) initially approached QualityHub after receiving multiple warning letters. QualityHub immediately performed audits and identified numerous quality systems issues — most of which pertained to one of the Client’s main facility. Churning and inconsistent staffing also compounded issues for the Client, as they lacked leadership who understood the need for effective quality management systems and the importance of being in compliance with the FDA’s regulations. They needed QualityHub not only to help resolve the  quality issues, and satisfy the terms of a consent decree, but also to fill in the gaps in staffing to make the needed corrective actions possible. QualityHub offered the Client the necessary remediation support required  to get back on track. 

Approach: Interim staffing provides insightful leadership

QualityHub laid the groundwork for the project by performing audits prior to the consent decree. We also met with FDA local district management, CDRH, ORA and attorneys. After analyzing the gaps in the quality system, we provided the Client with an acting/interim Quality Manager, Complaints Manager, a CAPA Manager, and a Sustaining Engineering Manager. Our interim executive program equipped the Client with trained professionals at the caliber needed to resolve these quality issues, and professionals who could assist the Client’s current staff. 

We also provided remediation team leads and Subject Matter Experts (SMEs) for the following departments: Corrections & Removals, Computer System Validation, Management Controls, Internal Audit, Risk Management and Design Controls, CAPA and other areas as needed. This way, the Client resolved the consent decree issues and took ownership of each project within the relevant department. 

QualityHub then collaborated with external FDA attorneys. We wanted to get a third party to provide additional insights, so we partnered with reputable DC-area lawyers familiar with the FDA and meeting consent decree requirements. This helped prepare the Client on how to handle FDA audits. Using our FDA readiness service, we ensured that every single person who would be interviewed by the FDA during an audit felt comfortable. QualityHub not only briefed them; we provided a full dress rehearsal on how to answer questions and provide appropriate documentation. 

Results: Establishing a lasting quality management infrastructure

At QualityHub, we understand that the right people paired with the right procedures can lead to more efficient and effective systems. Our interim leadership team transitioned  their knowledge and experiences to the Client’s team. We left the Client with a better informed team and a clearer understanding of how quality should be founded in proaction rather than reaction. The Client was able to resolve the issues laid out by the consent decree and resume normal business activities and redistribution of their key products.