The Quality Assurance Unit (QAU) of the
Research Support Center at UAMS provides comprehensive support services to
UAMS and UAMS affiliates.
With over 75 years of combined industrial,
governmental and academic experience, the QAU personnel are well positioned
to provide planning and essential support enabling the development of
well-designed, ethical studies that balance regulation with innovation in a
continuously changing environment.
The QAU focuses on six key systems of good
practice regulations for research and non-research entities:
-
Quality
Assurance
-
Facilities
and Equipment
-
Materials
-
Manufacturing and Processing
-
Packaging
and Labeling
-
laboratory controls
The services we provide
are:
-
Consultation Regarding Applicable
Regulations
-
Performance of Manufacturing Analysis
-
Determination of Facility Requirements
-
Review of Drug Substance
-
Planning and Establishment of
Manufacturing Process Controls
-
Establishment of Packaging and
Labeling Controls
-
Determination of Analytical and
Documentation Requirements
-
Qualification/Validation Services
-
Standard Operating Procedure
Development
-
Record Review and Quality Auditing
Services
-
Environmental Monitoring Consultation
Meet our QA Team:
-
Larry Parker, Interim Quality Assurance Manager - 686-6284
-
Beatrice Huey, GTP Specialist -
686-6286
-
Tracy Gatlin, GTP Specialist -
686-6803
Links:
