Good Laboratory Practice & Good Clinical Laboratory Practice

Topics

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