Basic Good Clinical Laboratory Practice (GCLP) – EMA Requirements for Laboratories Performing Clinical Trial Sample Analysis Masterclass
The analysis and evaluation of clinical trial samples are critical components of clinical research and contribute directly to the assessment of subject safety, efficacy endpoints and regulatory submissions. Laboratories performing work in support of clinical trials are expected to implement appropriate quality systems that ensure data integrity, reliability and compliance with regulatory requirements.
Count Every Second Until the Event
Date: 22, 23, 24 July 2025
Course Overview
This course provides a practical introduction to Good Clinical Laboratory Practice (GCLP) principles based on the EMA Reflection Paper for Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples (EMA/INS/GCP/532137/2010).
Participants will gain an understanding of the quality and operational requirements applicable to clinical trial laboratories, including organisation and responsibilities, quality systems, sample management, data integrity, documentation practices, subcontracting arrangements and inspection readiness.
The course combines regulatory expectations with practical implementation examples and opportunities to discuss best working practices and common compliance challenges.
The course is suitable for laboratory personnel, QA professionals and clinical research staff who are new to GCLP or require a practical understanding of laboratory requirements supporting clinical trial or as a refresher on the GCLP principles and requirements.
Key Topics
Introduction to GCLP and applicable regulatory requirements
EMA Reflection Paper requirements and practical implementation
Laboratory organisation and responsibilities; training
Quality Management Systems and documentation practices
Clinical trial requirements for laboratory procedures
Clinical trial sample management and chain of custody
Equipment qualification, calibration, and maintenance
Laboratory data integrity and record management
Quality Assurance programmes and internal audits
Managing deviations, investigations, and CAPAs
Vendor qualification and subcontracting activities
Inspection readiness and common regulatory observations
Best practices for implementing GCLP requirements
Common GCLP inspection observations and compliance challenges
Learning Outcomes
Delegates will
- Receive comprehensive course documentation.
- Participate in practical discussions and case studies.
- Certificate of completion issued by WeHive.
Meet Your Trainer
Orit Galperin, M.Sc., | CQE
Founder and Director,
Global Pharma QA Ltd.
Orit Galperin is a Quality Assurance professional with extensive international experience in regulated laboratory environments, specialising in GLP and GCLP compliance, quality systems, global auditing, regulatory expectations, and inspection readiness. She is the Founder and Director of Global Pharma QA Ltd., an independent consultancy providing quality assurance services, compliance support, and professional training to organisations operating within regulated life science environments.
Orit has extensive experience in developing and implementing Quality Management Systems, conducting GLP and GCLP audits worldwide, supporting organisations in achieving inspection readiness, and providing practical solutions to site-specific compliance challenges. Through Global Pharma QA and its global professional network, she also provides GMP and GCP QA expertise upon client request, ensuring that organisations receive the most appropriate specialist support for their regulatory and operational needs.
Orit combines technical Quality Assurance expertise with exceptional interpersonal and communication skills, enabling her to conduct audits in a constructive and collaborative manner. She believes that the greatest value of an audit is not simply identifying compliance gaps, but driving meaningful and sustainable quality improvements.
Her approach helps auditees understand and embrace audit observations as opportunities for improvement, fostering trust, engagement, and commitment to implementing effective corrective actions. This provides significant added value to sponsors and clients commissioning the audit by maximising the impact of audit findings and strengthening regulatory compliance and quality systems.
Ultimately, sponsors receive a high-value quality and compliance service that delivers measurable improvements, while auditees strengthen their processes and quality culture, creating a true win-win outcome for all stakeholders.
Request to Assign a Team Member!
