Case Study: Design Control Training

A medium-size multi-location manufacturer of both therapeutic and diagnostic products needed to improve their staff's understanding of design controls in response to 510(k) rejection and 483 observations.

AlvaMed developed a training and mentoring program that focused on design control principles and terminology in general with additional specialized training in particular areas such as requirements development. In addition to formal classroom training, AlvaMed provided mentoring in the form of document review as the staff started to implement the principles taught in the classroom.

Staff members who were initially trained and mentored have gone on to train other development groups within the company using a similar mentoring approach.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control