Aims and Objectives
This subject aims to introduce Good Laboratory Practices (GLP) to R&D laboratory managers, supervisors and other interested students, particularly those who are involved in regulated laboratories operating under GLPs.
On completion of this subject students will be able to:
- Proactively interpret the international guidance, codes of practice and regulations that govern non-clinical studies.
- Develop a list of procedures needed to ensure GLP compliance
- Apply quality assurance principles to non-clinical / safety studies
- Establish a quality management system in compliance with GLP standards
- State the role and responsibility of the QA Unit and Study Director
Content
This subject consists of 4 modules or topics:
#1 Review of FDA Regulations & Controls
This module is designed to provide participants with a better understanding of the regulatory role and controls exercised by FDA. The module explains how a regulatory audit is conducted.
- List the scope of FDA control.
- Describe the difference between guides and regulations.
- Describe the regulatory review process for registrations and GLP/GMP compliance
#2 Review of FDA CFR 58 and OECD GLP Regulations
This module is designed to provide participants with interpretation of the compliance requirements for GLP regulations :
- Understand the content and intent of CFR 58.
#3 GLPs and Documentation Compliance - Protocols, Records and Reports
This module is designed to provide participants with the GLP requirements for compliant documentation.
- State the required contents of a study protocol.
- State the required contents of a study report.
- State the requirements for securing and protecting data.
#4 Role and Responsibility of the QA Unit and Study Director
This module is designed to provide participants with a better understanding of the regulatory role and responsibility of the QA Unit and the Study Director.
- Describe the role of the QA Unit in a GLP laboratory.
- List the role and responsibility of the Study Director
- State the difference between GLP vs non-GLP studies
A workshop will be held to evaluate an example protocol against CFR 58 requirements and to interpret FDA warning letters compared to the CFR 58 regulations.
