Risk Management for Pharmaceutical Operations

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.

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

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

Content