About the course
In today’s global nature of health research and clinical trial conducts, it has been recognized that laboratories that process specimens from clinical trials have to follow a set of standards in order to maintain quality across different laboratories (WHO, 2009). Good Clinical Laboratory Practice (GCLP) applies principles established under Organization for Economic Cooperation and Development Good Laboratory Practices (GLP) that cover the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GCLP uses these principles relevant to the analysis of samples from a clinical trial and ensure that these guidelines are carried out in a way that is compliant with the ICH Good Clinical Practices.
Course Length: Two (2) days
Course Level: Introductory
What you’ll learn
• GCLP and the rationale for its application in clinical laboratories
• Organizational and personnel requirements of a GCLP-compliant laboratory
• Essential facility requirements for a GCLP-compliant clinical laboratory
• Appropriate specimen management throughout stages of analysis
• Process of issuance of results and the need for document and records retention
• Elements of SOP, process of preparation, approval and document control of SOP
• Principles of a quality system and how to apply them in a laboratory
What you’ll earn
Certificate of Completion: 90% attendance to training
Certificate of Participation: Course requirements met/passed
This training is designed for professionals who currently manage or work in a laboratory, having at least one (1) year of exposure in a clinical laboratory setting, especially those involved in clinical trials.
1. Fully accomplished and signed Application Form
2. Full payment two (2) weeks before the training
Please scan and send documents to email@example.com
Note: Course participants will be screened prior to training. RTC reserves the right to accept or deny application based on the screening. Substitutions are allowed as long as the substitute provides items no. 1 & 2 and passes the screening process.
Government: PHP 5,200
Private: PHP 5,700
Inclusive of materials and food (AM snack, Lunch, PM snack)
Maximum Number of Participants: 20 (first come, first serve basis)
Disclaimer: Published rate and schedule subject to change with or without prior notice.