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HES6410 Good Laboratory Practices for Non-Clinical Laboratories
(3 days)

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.

Format

The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.

Out of Class Assignment

Participants are offered the opportunity to complete a GMP assignment following completion of the course. This will be facilitated and supported remotely by SeerPharma's team of consultants, and successful completion will be rewarded with additional certification.

There is no additional charge for this.