Case Studies
Case I
A large, multinational, Fortune 500, Medical Device company was having serious problems with having a standard approach to conducting investigations. A team of corporate managers and PathWise consultants went around from site to site and assessed that some individuals and some sites were good at intuitively conducting investigations but there was not standard process or base line for doing so.
PathWise was able to work with a team of selected individuals to identify gaps in the investigation process and create a customized training program that could be rolled out all over the world. The next step was to actually implement the solution. PathWise spent 18 months with 6 consultants training world-wide on how to properly conduct investigations, be it a CAPA, complaints, or NCR investigation to name a few.
The end result was that the quality of their investigations increased. The number of unresolved, open investigations decreased, the number of repeat investigations reduced, and there were better able to maneuver through a number of FDA audits with no observations.
Case II
A small Medical Device company was having regulatory problems and was working one on one with the FDA on a monthly basis for over a year. The majority of their problems revolved around an inadequate Quality System. They were a small start-up with an excellent product but were having trouble sustaining systems while growing in head count.
PathWise was able to work with this manufacturer and first of all audit their current system. Right away there were a number of areas that needed improvement. PathWise was able to identify those problems, offer solutions to those problems, and actually help write procedures and create systems that would comply with the FDA.
The result was that after a few more months of refining and solving all of the FDA findings. This small Medical Device manufacturer was able to get their product back out on the market and continue to grow.
Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.
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