VCF2102

Product Development II B ( 3 points, SCA Band 2, 0.063 EFTSL)

Leader: Dr. Ben Boyd

Offered:
Parkville Second semester 2006 (Day)

Synopsis: The Therapeutic Goods Act and relevant regulations and orders, the Therapeutic Goods Administration, the Therapeutic Goods Register and the process of Listing and Registration, requirements for applications for listing and registration, the Electronic Lodgement Facility, international registration requirements and procedures. Physical and chemical product specifications, quality control procedures and test methods, stability testing. Students are expected to spend some time in the industry on an individual basis and to attend group visits at a selection of industrial sites.

Assessment: Examination (2 hours)

Prerequisites: All 1st year B.Form. Sci units