Skip to Content

Future Students - Courses

click here for a printable version of this page  

Computer Systems Validation Practices

Unit Code: HES6412




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.

 

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).

Back to Top

Aims & Objectives:

This unit of study aims to expand upon the material taught in HES6411 to give a practical outcome. At the end of this unit of study students will be able to:

  • Understand and be able to apply good testing practices.
  • Understand the importance of requirements traceability.
  • Identify the requirements of computer system suppliers to the industry.
  • Discuss relevant case studies and participate in workshops on all aspects of computer validation.
  • Apply the requirements of 21 CFR Part 11.


 

Back to Top

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).

Back to Top

Assessment:

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

Back to Top

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

Back to Top

Content:

  • Supplier Qualification and Software Development.
  • Validating a GxP Control System (Chromatography).
  • Legacy Systems, Risk Assessment and Remediation.
  • Validating a Quality Assurance Control System.
  • Current regulatory Trends / Requirements.
  • Introduction to GxP issues in relation to Computer system usage.
  • Application of ERES principles to computer systems.
  • Auditing of Suppliers, Suppliers requirements and Configurable Off The Shelf (COTS).
  • Good Testing Practices.

Back to Top

Reading Materials:

A Course Reference Manual.
Industry specific case study & workshop materials.
Textbook: printed notes will be supplied.

Back to Top

Textbooks:

Printed notes will be supplied

Back to Top