Risk Management for Pharmaceutical Operations
Unit code: HES6429
|Credit points||12.5 Credit Points|
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, HES6402and HES6403 is therefore desirable.
This subject is an elective 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
To facilitate the development of knowledge, and expertise in risk management principles and practical risk evaluation techniques, in order to identify and manage risks in the development, manufacture and marketing of pharmaceuticals.
At the end of this unit students will be able to:
- Articulate and evaluate the principles influencing the practice of risk management in pharmaceutical operations; make judgments based on risk management principles.
- Utilise risk evaluation techniques to analysis pharmaceutical products, operations and systems; and propose control strategies and plans to mitigate unacceptable risk and loss to the organisation.
- Demonstrate skills in writing reports. Research, assess and evaluate information. Evaluate data and identify facts.
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
Regulatory guidance for applying risk management in pharmaceuticals – FDA, EU/PICs/TGA, ICH
Quality by Design - Risk analysis in design and development of products
Development a of Risk Management Master Plan