Postgraduate Courses > Postgrad > Swinburne University of Technology, Melbourne, Australia

Postgrad

> Postgrad
> Postgrad Courses

Print or email this page:

Good Laboratory Practices (for Non-Clinical Laboratories)

Unit Code: HES6410

Duration

Contact Hours

Campus

Prerequisite

Corequisite

1 Semester or Teaching Period

30 Hours

External Venue, Hawthorn

Nil, however a basic understanding of, GMP and practical work experience within the industry is assumed. Completion, or co-completion, of HES6401, HES6402 and HES6403 is therefore desirable.

HES6401 International Good Manufacturing Practices and Quality Assurance

HES6402 Good Manufacturing Practices for Manufacturing Operations

HES6403 Validation Principles

Credit Points: 12.5 Credit Points

Related Course/s:

An elective unit of study in the Graduate Certificate of Science (Good Manufacturing Practices), Graduate Diploma of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices and Quality Management).

Aims & Objectives:

This unit of study 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. At the end of this unit of study students will be able to:

Review of FDA Regulations & Controls
List the scope of FDA control.
Describe the difference between guides and regulations.
Describe the regulatory review process for registrations and GLP/GMP compliance.
Describe the role of the QA Unit in a GLP laboratory.
Review of FDA CFR 58 and OECD GLP Regulations
Understand the content and intent of CFR 58.
Using CFR 58, locate the clauses relating to specific GLP requirements
GLPs and Documentation Compliance – Protocols, Records and Reports
State the required contents of a study protocol.
State the required contents of a study report.
State the requirementsfor securing and protecting data.

Teaching Methods:

Lectures/Tutorials, Laboratory and/or experiential off-campus learning, Case studies based on actual events that have occurred in the pharmaceutical and related industries will be used, Web Based Unit Presence (Blackboard).

Assessment:

Assignments (40%)
Test (20%)
Portfolio (10%)
Examination (30%)

Generic Skills Outcomes:

Students will be provided with feedback during the assessment for this unit of study on their progress in attaining the following generic skills:

Teamwork skills,
Analysis skills,
Problem solving skills,
Communications skills,
Ability to tackle unfamiliar problems, and the
Ability to work independently

Content:

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.
Review of FDA CFR 58 and OECD GLP Regulations: This module is designed to provide participants with detailed understanding of the CFR 58 GLP regulations.
GLPs and Documentation Compliance – Protocols, Records and Reports : This module is designed to provide participants with the GLP requirements for compliant documentation.
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.

Reading Materials:

Lecture notes (provided via Blackboard)

Textbooks:

Printed notes will be supplied