Xavier University and FDA train about risk and patient safety

February 8, 2011

Xavier University welcomed more than 67 leading medical device professionals from six states for training on managing risk and ensuring patient safety in the design, development and distribution of medical devices.

The event featured medical device specialists engaging industry professionals at all levels with in-depth discussion.

“CAPA, Risk Assessment, the FDA… and YOU” addressed the risk management process of Corrective Action/Preventive Action (CAPA). FDA presented key issues faced by medical device manufacturers who are faced with the challenge of getting products to market safely and efficiently, addressing risk throughout the process, and initiating corrections and removals from the market when indicated.

Lead presenter Gina Brackett (left in photo) is a compliance officer and was previously the medical device specialist with the FDA Cincinnati District Office. She emphasized that a robust CAPA system is a living process that must be connected with design controls in order to ensure not only correction but prevention. The session made it clear that the FDA is committed to ensuring the safety and quality of devices through a rigorous inspection process with which companies must comply.

Laureen Geniusz (right in photo), investigator and medical device specialist with FDA Cincinnati District Office, shared examples of what firms need to consider for the CAPA system in order to comply with regulations and FDA expectations. Dr. Marla Phillips, Director at Xavier University and former Head of Quality for the Merck North Carolina facility, provided practical examples and tools to better understand how to fully implement risk management throughout the product lifecycle.

“At Xavier University, we’re pleased to bring such powerful training to the medical device industry,” said Phillips. “An effective Corrective Action/Preventive Action process can result in better design, more efficient processes, and greater assurance of patient safety.”

The FDA and Xavier University are co-sponsoring the Global Medical Device Conference in May 3-6, 2011. Speakers will include Kim Trautman, Phil Pontikos, Hugh McClure, Gina Brackett, Kenneth Ouriel, and Monica Wilkins. For more details, visit www.XavierMedCon.com.