This two-day course with workshop and case examples is designed for Managers and Sponsors of GLP and/or GCP Studies to develop a working knowledge of GLP and GCP requirements to support implementation of the Quality Management System in a GLP and/or GCP setting.
Regulatory requirements & obligations for Sponsors of GCP studies
Data integrity guidelines, principles & risk assessments
Data integrity case studies from the GLP and GCP Laboratory
Data governance, quality assurance & metrics