Abbott Vascular Medical Device Facility

Objective

Abbot requested that Commissioning Agents prepare their Medical Device facility and staff by performing internal compliance audits, and to prepare them to pass the upcoming FDA audit.

Process

Our experts provided training to their quality staff on how to prepare rooms and facility for an FDA audit. The training covered reviewing of data packages making sure that any and all deviations were well documented and the staff presenting the package could do so in a confident manner. The internal audit process helped them develop the methods of presenting data to the FDA, how to answer questions, how to prepare the entire site staff on what not to say in hallways, cafeterias, bathrooms, etc.

Services

The training and audits developed a tour route and guides, provided role playing for key people that would be interviewed by the FDA such that they were well versed and comfortable in speaking with the agency. They have been inspected by the FDA and EMA with either no or minor observations.

Project Success

The project successfully identified several areas that needed attention and allowed Abbott Vascular time to make the necessary corrections prior to them being addressed in agency inspections.

Time Frame

4 Years

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