GLP Consulting

Specializing in FDA Good Laboratory Practice Compliance for Medical Devices and Combination Products

GLP Consulting Services offers a full range of contract GLP quality assurance, regulatory compliance consulting, and preclinical study support

Over 25 years of preclinical research experience in the medical device industry and in academia

Debra Ann Bridges, RQAP-GLP

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.

Services

Quality Assurance, Compliance, Educational Programs, and Research Services are available.

QA and Compliance
  • Quality Assurance consulting
  • Compliance inspections
  • Data and report audits
  • Quality systems inspections
  • Assistance in developing and implementing GLP compliance programs and quality systems for testing facilities
  • Assistance in locating Contract Research Organizations for device studies
  • Educational programs
  • USDA compliance assessments and applicable international standards
Education Programs
  • Study Director and Management GLP Training
  • A Practical Approach to Good Laboratory Practice Regulations – Sponsor Training
  • GLP Training for Animal Care and Support Personnel
  • Quality Assurance Training
Customized in-house educational programs tailored to meet the educational needs of the audience. All programs offer practical information to assist personnel in interpreting and applying the regulations to medical device studies in your research environment. Contact for pricing and availability.
Research Services
  • Preclinical Study Monitoring
    • Coordinate study activity
    • Oversee study progress and data collection
    • Data management
    • Respond to compliance issues
    • Serve as sponsor representative
  • Assistance with protocol development
  • Developing Standard Operating Procedures

Contact GLP Consulting Services

Debra Bridges, RQAP-GLP

(361)781-2325

dbridges@glpconsulting.com