This Good Laboratory Practice (GLP) nonclinical training course introduces learners to the general requirements for the competence of testing and calibration laboratories as outlined in ISO/IEC 17025:2017.
Topics you’ll learn about in this course include:
- The importance of impartiality and confidentiality
- Laboratory organisation and management structure
- Resources - personnel, facilities, environment and equipment
- Metrological traceability
- Test methods and method validation
- Sampling plan and sampling method
- Evaluation of measurement uncertainty
- Technical records
- Test results and reporting
- Complaints and nonconformance handling
- Management system - documentation, corrective actions, internal audits and management reviews
Speaker
Kelly ThomasWho Should Attend
This course is intended for all industries developing products that require FDA approval for research or marketing including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. It will be beneficial to anyone planning, conducting, monitoring, managing, supervising, or otherwise supporting non-clinical studies. This program is especially valuable for onboarding any employee involved directly or indirectly in nonclinical study planning and execution, to ensure alignment on GLP culture and fundamentals within your organization prior to engaging in work that impacts GLP compliance.- Laboratory personnel involved in non-clinical studies
- Quality assurance and quality control professionals
- Regulatory affairs specialists
- Study director
- Facility management
- Archivists
