The QA team performs internal audits and audits of vendors used by CTC . They also take on GLP, GMP, GCP and ISO audit assignments of medicinal and device trials or perform other QA services such as developing GxP SOPs and provide regulatory advice for other companies.
- Development and review of standard operating procedures (SOPs), work instructions and templates in collaboration with CTC’s Directors (in accordance with GxP and ISO standards)
- Provide GxP trainings including e.g. ICH GCP, Annex 13, ERES, ISO14155, ISO 20916 and GDPR
- External GLP, GMP and GCP audits