VPS3101 - Product development II

Leader(s): Dr Ben Boyd

Offered

Parkville First semester 2009 (Day)

Synopsis

• intellectual property
• QA/QC/ISO/HACCP quality management
• HACCP
• ISO standards
• preformulation
• packaging
• chemical stability
• raw materials and product design

Objectives

After completing this unit students will:

1. Assess the role of oxidative processes in food and drug stability;
2. Discuss how the properties of a drug will influence the choice of formulation and the strategy to overcome potential problem associated with the formulation;
3. Be given information on the bulk, physicochemical and stability properties of a drug, provide a clear strategy for the choice and development of a formulation of that drug;
4. Discuss the properties of materials used for packaging;
5. Discuss the considerations in the use of glass, plastic and rubber packaging materials;
6. Evaluate suggested packaging strategies;
7. Understand quality control and quality assurance systems;
8. Have a working knowledge of HACCP;
9. Be acquainted with the ISO series of standards;
10. Understand the patenting process;
11. Be able to write an invention record;
12. Be able to keep records and laboratory notes in a manner suitable for protection of intellectual property;
13. Know how to go about sourcing raw materials.

Assessment

invention record: 10%; practical: 10%; final exam: 80% (students must attain at least 40% in this exam to pass the course)

Contact hours

36 1 hour lectures, four 3 hour practical tutorials and 24 hours of self directed learning

Prerequisites

VPS2102 Product development I

Additional information on this unit is available from the faculty at:

http://www.monash.edu.au/muso/