Clinical Trials » Quality Affairs
The Quality Affairs office provides expertise in the areas of GxP to Upstate faculty and departments, including the following:
- Quality Management System: Implementation of systems that are compliant to GCP and GLP regulations.
- Training on GCP and GLP, setting up training procedures and tracking systems
- Assess Documentation: Proper documentation is key in any clinical study. Regulatory bodies and sponsors often ask first to see documentation as the first step in any audit.
- Assistance with external audits: Sponsors and regulatory bodies can audit studies at any time. Quality affairs can help navigate those audits. Pre-audit preparation, planning and coaching is also available.
- Navigate corrective and preventative actions (CAPA) are a key part of any quality management system
- Help with risk assessments using a risk based approach to policies and procedures is expected in today’s regulatory environment.
- Evaluate and help with the implementation of GCP/GLP activities
For assistance, please contact: