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:

1. Quality Assurance

2. Facilities and Equipment

3. Materials

4. Manufacturing and Processing

5. Packaging and Labeling

6. 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, Quality Assurance Manager - 686-6284

• Beatrice Huey, GTP Specialist - 686-6286

• Tracy Gatlin, GTP Specialist - 686-6803

Courses:

• Good Tissue Practice for CRS

Links:

• Good Tissue Practice

• Good Manufacturing Practice

• cGMP 21 CFR 210

• cGMP 21 CFR 211

• cGLP 21 CFR 58

• cGTP 21 CFR 1270

• cGTP 21 CFR 1271