Over her career, she has been able to provide expert advice to tackle the quality and regulatory compliance needs of bioscience companies worldwide. In addition to her industry experience, she has a Master's Degree in Quality Assurance and Regulatory Affairs from the Temple University School of Pharmacy and she is a Certified Quality Auditor (CQA) and a Certified Quality Engineer (CQE) by the American Society for Quality.
For the past two years, she successfully led Vision 28 LLC as the President & CEO. Prior to Vision 28, she held Director of Quality and Regulatory roles at Acumed and CompView Medical. She also spent time at Welch Allyn, AstraZeneca, Shire, and DuPont Pharmaceutical Company (now Bristol-Myers Squibb.)
More about The FDA Group
The FDA Group is a global leader in GxP auditing & remediation and regulatory services. Their purpose is to empower our clients to bring their life-changing healthcare products to the market and keep them there.
The FDA Group is able to do this by providing a world-class service experience. The way in which The FDA Group ensures a world-class service experience is by its proprietary talent selection process coupled with its deep-rooted corporate culture that includes 31 Fundamentals. These Fundamentals are the heart-beat of the organization and are focused on four areas: Core Values, Focus on Service, The Collaborative Way, and Personal Effectiveness.
For more information, contact:
Andrea Houlne
(508) 926-8330
info@thefdagroup.com