Good Clinical and Laboratory Practice (GCLP) Compliance Program
$ 200
Addresses the combined requirements of GCP and GLP as they apply to laboratories that support clinical trials, safeguarding data quality and regulatory compliance.
Course Description
This integrated program addresses the combined requirements of Good Clinical Practice and Good Laboratory Practice as they apply to laboratories that support clinical trials. Participants learn to implement GCLP systems that safeguard the quality, integrity, and regulatory compliance of laboratory data generated within clinical research contexts.
Program Modules
- Introduction to GCLP: Rationale, Frameworks & Regulatory Context
- Laboratory Quality Systems: SOPs, Training, Equipment & Calibration
- Sample Management in Clinical Trials: Collection, Labelling & Chain of Custody
- Reference Ranges, Method Validation & Analytical Quality in GCLP
- Data Management: Electronic Systems, Data Integrity & Audit Trails
- Proficiency Testing, Internal QC & External Quality Assurance in GCLP
- Protocol Adherence, Deviations & Change Control in Clinical Laboratory Testing
- GCLP Audits, Regulatory Inspections & Laboratory Compliance Documentation
Who Should Attend
Clinical trial laboratory scientists, quality assurance officers, clinical research coordinators, laboratory managers in research settings, and regulatory compliance professionals.
Course Details
- Duration: 5 Days
- Investment: $200 per participant