GxP and Quality Auditing Practices
Unit code: HES6415
|Credit points||12.5 Credit Points|
|Duration||1 Semester or teaching period|
|Contact hours||30 Hours|
|Campus||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.
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 and objectives
This unit of study aims to systematically plan and conduct a GxP audit. At the end of this unit of study, students will have conducted a mock audit, assessed GXP risks and provided a written report on compliance status.
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).
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
GMP audit schedule, managing regulatory audits in an effective manner, what to expect from GMP licensing audits.