
Good Laboratory Practice & Good Clinical Laboratory Practice
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Location:
- View on a map
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Contact:
- Organiser: Fleming Events
- Name: Julie Richardson
- Email: julie.richardson@pharmafe.com
- Telephone: +421257272100
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