1 Semester

30 Hours

External Venue, Hawthorn

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

Co-completion of HES6401, HES6402 and HES6403 is desirable.

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) (Honours).

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 parmaceutical and related industries, web based unit presence (Blackboard).

Assessment:

Test 10%, Assignments 50%, Exam 40% 

Generic Skills Outcomes:

Students are expected to enhance several of their graduate attributes during this unit of study and should consult with your lecturer if not clear as to how this unit of study achieves this. The graduate attributes which relate to this unit of study help to produce students who:

• Are capable in their chosen professional, vocational or study areas.
• Are entrepreneurial in contributing to innovation and development within their business, workplace, or community.
• Operate effectively and ethically in work and community situations.
• Are adaptable and manage change.
• Are aware of environments in which they will be contributing.

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: