Our client, a global leader in cardiac care, acute care and home healthcare products contracted with EG Life Sciences to provide consultant resources to address Quality System deficiencies identified as a result of a facility inspection by the U.S. FDA. Following the inspection of the client’s southern California manufacturing facility, the FDA issued a warning letter listing several areas of noncompliance to the requirements listed in 21 CFR Part 820 regulation.
One of the areas cited in the warning letter involved a significant backlog that existed of approximately 4500 complaints which were open well past their closure due dates. This backlog represented a major systemic breakdown in the company’s post market surveillance system, one of the most important processes available to receive and evaluate product performance data. The client requested that EG Life Sciences source and secure a team of seasoned senior complaint handling specialists to review, investigate, and close the significant list of overdue product complaints. In addition to remediating the open complaints, the complaint specialists were also responsible for revising the processes to effectively handle the influx of new complaints coming in each month. The client requested this group complete the project within six months.
A roster of competent consultant candidates was quickly identified by the internal recruiting team, and as part of the rigorous internal screening process employed by the Life Sciences staff, the large group was narrowed down to a final team of high performing individuals one week after receiving the request. The assembled team was introduced and on-boarded at the client’s site approximately three weeks after the initial client contact with EG. During their first week on-site at the client, the consultant group received an intense but thorough training on the processes that they would be required to comply with, and the products that would be the subject of the complaints to be handled. Once the training was completed, the consultant group jumped in and immediately began to make an impact on the backlog.
Daily and weekly progress was tracked by the client against agreed upon goals for each team member. In addition, the EG Life Sciences internal team conducted a weekly conference call with the consultants to check on their progress and to resolve any issues that were inhibiting progress and creating delays in the schedule. Periodic adjustments were made to ensure completion of the project by the required completion milestone.
An EG Life Sciences core competency and market differentiator is our ability to quickly assess problem attributes, allowing us to rapidly source and select the best team to be deployed to the client. In this case, the selection of the EG Life Sciences team allowed the client to successfully navigate and resolve the FDA warning letter issues in a timely manner. The consultant group executed flawlessly on the project plan providing the client with the specific expertise and skills they needed, at a price that fit into their budget, and freed up their internal resources to focus on other areas of need.