Quality Compliance

Quality Compliance staff supporting the Translational Core laboratories have an extensive background in compliance and come from the parenteral pharmaceutical industry, blood/tissue banking organizations and Contract Research Organizations (CROs). They provide the cores with comprehensive skills in the interpretation and application of current Good Manufacturing Practices (cGMP), Good Tissue Practices (GTP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), College of American Pathologists/ Clinical Laboratory Improvement Amendments (CAP/CLIA) requirements, guidelines and regulations. In addition Quality Compliance staff are certified by the American Society of Quality (ASQ) as Certified Auditors.   

The Quality Compliance Unit is a part of the CCHMC Office of Research Compliance and Regulatory Affairs (ORCRA). Quality Compliance personnel are responsible for quality assurance within the Translational Core Laboratories to provide regulatory and quality direction and support. ORCRA ensures that each compliance unit has a reporting mechanism that is separate from the area being monitored.  Quality Complaince staff have provided consultation services and training to various academic and industry sponsors on GLP study design, BioRepository requirements, GMP requirements, and cleanroom design, control and validation.

Our Quality Compliance team is committed to ensuring that all operations within the core meet the highest quality standards. Contact us for more information on the Quality Compliance Programs for the Translation Core Laboratories.