The QA specialist works with tissue establishments to ensure compliance with quality aspects as set forth by 21 CRR 1271 Good Tissue Practices (GTP).
The QA specialist is responsible for the following:
- Ensuring that tissue establishments establish and maintain appropriate procedures relating to core GTP requirements, and ensuring compliance with the requirements of Sec. 1271.180 with respect to such procedures, including review, approval, and revision;
- Ensuring that procedures exist for receiving, investigating, evaluating, and documenting information relating to core GTP requirements, including complaints, and for sharing any information pertaining to the possible contamination of the human cells, tissues, and cellular and tissue-based products (HCT/P’s) or the potential for transmission of a communicable disease by the HCT/P;
- Ensuring that appropriate corrective actions relating to core GTP requirements, including re-audits of deficiencies, are taken and documented, as necessary;
- Ensuring the proper training and education of personnel involved in activities related to core GTP requirements;
- Establishing and maintaining appropriate monitoring systems as necessary to comply with the requirements of this subpart (e.g., environmental monitoring);
- Investigating and documenting HCT/P deviations and trends of HCT/P deviations relating to core GTP requirements and making reports if required under Sec. 1271.350(b) or other applicable regulations, and
- Conducting annual quality audits as defined in Sec. 1271.3(gg), of activities related to core GTP requirements.
- Beatrice Huey, Good Tissue Practice Specialist, 501-686-6286