Good Laboratory Practice & Good Clinical Laboratory Practice

https://fleming.events/good-laboratory-practice-good-clinical-laboratory-practice-training/

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.

Topics

• Regulatory requirements & obligations for Sponsors of GLP studies
• Regulatory requirements & obligations for Sponsors of GCP studies
• Outsourcing considerations
• Sponsor oversight, vendor evaluation, for GLP and GCP compliance
• Differences between GLP and Clinical Laboratory Expectations
• Data integrity guidelines, principles & risk assessments
• Data integrity case studies from the GLP and GCP Laboratory
• Data governance, quality assurance & metrics

Benefits of attending

• Gain knowledge of GLP and GCP sponsor requirements and the similarities and differences in GLP and GCP expectations
• Get an overview of practical vendor selection considerations and documentation to support regulatory audit and inspections using a risk-based approach
• Benefit from practical considerations for data integrity in the laboratory from both a GCP and GLP perspective