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 students to the necessity for validation in IT and to train students for the need to be prepared for auditing etc. in the real world.

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

• Understand the requirements of the regulations and how they relate to the guidance documents and Good Automated Manufacturing Practices (GAMP).
• Understand all stages of the software development lifecycle and their related documentation.
• Understand supplier audit concepts and the importance of the user/supplier relationship.
• Learn the concepts of risk assessment.
• Understand the QA & IT terminology.
• Identify the requirements of computer system suppliers to the industry.
• Discuss relevant case studies and participate in workshops on all aspects of computer validation.

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:

Test 10%, Assignments 50%, Exam 40%

Generic Skills Outcomes:

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

• Are capable in their chosen professional, vocational or study areas.
• Operate effectively and ethically in work and community situations.
• Are aware of environments in which they will be contributing.

Content:

• Principles of Computer Validation.
• Understanding the GAMP Approach to Computer Systems Validation (CSV).
• Electronic Records and Electronic Signatures.
• CSV Documentation and Testing.
• Current regulatory Trends / Requirements.
• Introduction to GxP issues in relation to computer system usage.
• Supplying to the pharmaceutical industry.

Reading Materials:

A Course Reference Manual.
Industry specific case study & workshop materials.
Lecture notes (provided via Blackboard).

Textbooks: