Ms. Bridges' experience encompasses over 25 years with specialization in medical device preclinical research. Debra provided leadership and was instrumental in developing a large animal preclinical research facility and GLP program at a major land grant university where she served as Associate Director of Operations and Regulatory Compliance for 12 years. Having also served as the Biomedical Testing Facility Manager for an international cardiac pacemaker company for 10 years she understands industry needs. The unique combination of academic and industry experience is an asset for sponsors working with university laboratories. Ms. Bridges’ practical approach and sensitivity to sponsor and testing facility needs adds value during the site selection process and through the study lifecycle. She has inspected research laboratories in the US, Canada, and Japan and maintains current knowledge of the ever changing regulatory environment. Clients have included top medical device manufacturers in cardiovascular and neurovascular interventional areas, small start-up companies, contract research organizations, and academic institutions. With a solid research background she offers insight into study protocol design and GLP study implementation.
Ms. Bridges is a Registered Quality Assurance Professional (GLP) through the Society of Quality Assurance, member of the Society of Quality Assurance, founding member and Past Chair of the Medical Device Specialty Section and current Vice Chair, member of the University Specialty Section of SQA, and a Licensed Veterinary Technician in the State of Texas.
Resume and references are available upon request.
Quality Assurance, Compliance, Educational Programs, and Research Services are available.
Debra Bridges, RQAP-GLP