Specialist Certificate in Cold Chain Management (Pharmaceuticals & Medical Devices)

Course details

Asia is emerging as a global powerhouse in biomedical and healthcare industries. The sheer size of the market, the high growth rate and the complicated infrastructure poses high rewards and risks for the industry players, as well as logistics service providers.

Singapore offers Asia's best healthcare system, with ten accredited hospitals and three medical centres. The country attracted 400,000 foreign patients in 2006, with the number projected to reach 1 million in 2012. Singapore achieved "Best Medical / Wellness Tourism Destinations" (By Travel / Weekly Asia Industry Awards for two years consecutively in 2007-2008, and was ranked 4th Best Healthcare Infrastructure (IMD World Competitiveness Yearbook 2009).

These conditions bode well for the pharmaceuticals and logistics industry. The market for cold chain packaging and transport services is projected to grow from $6.9 billion to $8.7 billion by 2015. This is driven by the strong demand from pharmaceutical companies that need specialized storage and transport of drugs, clinical trials and test samples. The pharmaceutical companies will require cold chain logistics service providers to handle time and temperature sensitive products. As such, 17 of 25 largest 3PLs in the world have based their operations in Singapore, with many offering cold chain logistics. 

Designed For

Logistics professionals working in cold chain and related services with a focus on the pharmaceutical & medical device sector; persons holding the following positions may find the course extremely useful:

• Senior and mid level managers involved in cold chain design
• Operations and logistics managers
• Warehouse managers and supervisors
• Transport managers and supervisors
• Third-party logistics personnel looking to improve their current operations, or providing cold chain services
• Managers and executives in pharmaceuticals industry
• Quality Assurance managers
• Consultants

Certification

A Certificate of Achievement will be awarded upon successful completion of the course with 75% attendance.

Coverage

Introduction to Cold Chain Logistics

• Definitions and Terminologies
• Applications of Cold Chain Management
• Equipment, Devices and Technologies
• Role of Logisticians in Cold Chain

Cold Chain for Medical Products

• Medical Products
• Effects of Temperature Changes
• Medical Products Supply Chain
• Traceability
• Cost of Service

Storage and Control

• Cold Chain Storage Facilities
• Warehouse Layout and Goods Flow for Cold Chain
• Maintaining & Monitoring of Storage Conditions (Temperature, Humidity)
• Control Systems for Contingent Storage Conditions
• Analyzing Requirements for Storage, Handling and Transportation Involving Airline Transfers
• Contingency Plan for Delays at Airports and Temperature Excursions

Inventory Management

• Security of Stocks in Warehouse & in-Transit
• Cleanliness & Pest Control in Warehouse
• Receipt of Temperature-Sensitive Goods
• Stock Handling during Picking & Preparation for Delivery
• Training of Warehouse Staff on Cold Chain Storage

Distribution Management

• Key Points in Distribution of Medical Products
• What is Complaint, Product Recall & Field Safety Corrective Action
• Goods Return of Medical Products Requiring Cold Chain
• Disposal of Medical Products

Packaging

• Packaging Standards and Technologies for Cold Chain
• Packaging and Repackaging Processes
• Quality Oversight on Packaging Process
• Contingent Planning for Cold Chain Packaging
• Safety Procedures

Managing 3PLs

• Introduction and Definition of 3PL
• Scope of work for 3PL in Cold Chain Logistics Execution
• 3PL's role in transport, storage and handling of Cold Chain Products
• Case Study of 3PL's involvement in Cold Chain Logistics

IT Innovations

• Current IT Advancements for Logistics Applications
• Temp Tales, Logging and Tracking Devices
• IT Documentation and Records Management
• Future of IT Applications for Cold Chain

Regulatory Requirements

• Types of Certifications and Licenses Required by H.S.A. for Import & Wholesale of Medical Products
• Overview on Requirements of Good Distribution Practice for Medicinal Products and Medical Devices for Importers & Wholesalers
• Licenses Issues

Audit and Quality Systems

• Internal & External Audits
• Standard Operating Procedures (S.O.P.)
• Prepare, Approval, Amendment, Control & Dispose of Quality Documents
• Course Review