Auditor, GCP Responsibilities The GCP Auditor is responsible for quality assurance auditing of all activities subject to the, “ICH Good Clinical Practice: Consolidated Guideline,” (GCPs), supporting a program of quality assurance (QA) to ensure that AGN project data and summary statements are of known and documented quality. Summary of Responsibilities: Ler mais
Responsibilities The Director, GCP will be required to oversee all and participate in, quality assurance auditing of all activities subject to the, “ICH Good Clinical/Laboratory Practice: Consolidated Guideline,” (GCP/GLP’s), supporting a program of quality assurance (QA) to ensure that Allergan project data and summary statements are of known and documented Ler mais
Responsibilities Assisting in the design and execution of high quality clinical studies in compliance with FDA and ICH requirements. Function as a primary liaison to clinical investigators/site staff. Identify, qualify, initiate, monitor and close out clinical sites. Co-monitor with CRO when issues arise with the site. Assist in the selection Ler mais
GCP Audit. Part C. Curso de auditoria GCP. Data Fabrication and Falsification. Access granted on May 08,2023