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Program scheduleSemester 1 (March-June):
Semester 2 (July-December) :
COURSE DESCRIPTIONS:MANF8420 MANAGING MANUFACTURING OPERATIONS(offered annually in Semester 1, March-June) Principles of Quality management. Designing products for Quality. Concurrent product and process design .Strategic quality planning. Lean manufacturing. Just in time manufacturing . Human resources in operations management. Reengineering. The voice of the customer. The voice of the market. Benchmarking. Failure modes and effect analysis. Statistical tools for quality management. Statistical Process Control. Six Sigma. Process Capability. Process Stability. Quality costs. Acceptance Sampling and Inspection. Preventive maintenance. Project management. Risk assessment and cost effective validation. MANF8430 UNDERSTANDING GOOD MANUFACTURING PRACTICE(offered annually in Semester 1, March-June) Understanding the basic processes of product manufacture. Basic principles of analytical approaches, Analysis of products, principles of sterility testing, principles of scale-up. Product quality review. Process planning, analysis and testing. Change control. Variation Analysis. Batch record review. Product release procedures. Good distribution practice. The audit process. Certification and Supplier audits. Documentation management. Good laboratory practice, Analytical certificates compliance. Implementing and Validating the Quality system. MANF8471 MANUFACTURING STRATEGY(offered annually in Semester 2, July-Dec) Sustainable competitive strategies in manufacturing. Core Competencies. Corporate, Business, Operational strategies. Process Planning and Technology decisions. Value-added manufacturing. Customer Relationship Management(CRM) . Supplier development programs. Logistics . Material Requirements Planning. Inventory management. Scheduling. Design for Manufacture. Design for reuse/disposal. Capacity Planning and production planning. Supply chain management. Understanding the importance of premises, plant, starting materials, packing. Effective documentation and validation. PHPH9104 LAW, ETHICS AND REGULATIONS OF MEDICINES(offered annually in Semester 2, July-Dec) Pharmaceutical Regulations, Administration and law in Australia, New Zealand and overseas, Prescription Medicine, Non-prescription Medicine, Complementary Medicine, Medical Devices Regulations, Traceability, Links with the other agencies such as Customs, Cosmetics industry and the Food Standards. Duties and responsibilities of the Authorised Person, Role of Sponsors, manufacturers and contract manufacturing. Importance of drug master files. The marketing authorisation . Analysis of biologics. Commercial agreements. |
