Mr. Barile has over thirty-five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the executive quality assurance position in both start-up and large multi-national corporations, specializing in difficult turnaround situations. His depth of experience in both line and corporate management has given Mr. Barile a unique and practical hands-on expertise with a wide variety of challenges over a diverse range of product technologies.

Mr. Barile is Managing Partner of Barile & Associates Inc., a consulting firm comprised of a group of over forty senior quality, regulatory, operations and manufacturing professionals. Barile and Associates provides a range of services including software, process and equipment validation as well as quality system consulting, training, staffing, organizational development, auditing and 483/Warning Letter resolution and are experts in US FDA and international regulatory requirements. They have offices in North America, the Middle East, Asia and Europe.