Good Lab Practices – Awareness & Implementation

Course Objectives

Upon completion of this programme, the participants will be able to:

• Document operations and activities in accordance with OECD & Malaysian GLP requirements
• Plan and conduct a study that meets OECD & Malaysian GLP requirements
• Effectively record study raw data
• Complete a study report that is GLP complaint

Target Audience

• Lab Technician
• Lab Engineers
• Junior Chemist / Microbiologist
• QA / QC Technician / Staff / Personals
• Laboratory Personnel responsible for implementing GLP systems in facilities.

Methodology

This stimulating program will maximizes the understanding and learning through lecture, discussion, case studies and practical activities.

Course Modules

• Module 1 – Overview Of GLP
• Module 2 – Scope Of GLP
• Module 3 – GMP Vs GLP & GCP Vs GLP
• Module 4 – Setting Up GLP System
• Module 5 – The Fundamentals Of GLP
• Module 6 – Multi Case Studies & Discussion
• Module 7 – Apparatus, Materials, Reagents, Volumetric Glassware
• Module 8 – Preparation Of Standard Solutions And Reagent
• Module 9 – Test System
• Module 10 – Computerized Systems
• Module 11 – Calibration Of Equipment And Instruments
• Module 12 – Test And Items
• Module 13 – Study Plans
• Module 14 : Reporting Study Results
• Module 15 – Storage And Retention Of Records
• Module 16 – Reference
• Module 17 – Implementation Of Malaysian GLP
• Module 18 – Safety Issues & Ethical Issues
• Module 19 – Group Discussion
• Module 20 – Presentation
• Module 21 – Verification & Validation Discussion
• Module 22 – Internal And External Verification / Audit Discussion