Temperature Control Regulations

Course Objectives

By the end of this course the trainees should be able to:
Anticipate the logistical and regulatory needs of the global healthcare industry.
Accept & handle time and temperature-sensitive healthcare shipments transported by air correctly.
Use proper documentations for handle time and temperature-sensitive healthcare shipments.
Identify potential risks at critical points in the cold chain.
Comply with IATA Temperature Control Regulations (TCR) & IATA CEIV Pharma and GDP Requirements.
Identify container types and know their respective build-up, inspection and storage procedures.
Select suitable facilities & equipment for your temperature-controlled operations

Course Contents

Module 1: Healthcare Industry Regulations
Overview of the Global Healthcare Industry
 
The Regulatory Environment
 
Total Module 1
 
Module 2: Temperature Management in the Healthcare Supply Chain
Air Transport Logistics for Healthcare Products
 
Understanding Temperature Management
 
Total Module 2
 
Module 3: Packaging
Heat
 
Active & Passive Packaging Systems
 
Total Module 3
 
Module 4: Making the shipment “Ready for Carriage”
Shipper & Carrier Responsibilities
 
Documentation and Labelling
 
Recommended Procedures
 
Total Module 4
 
Module 5: Compliance (IATA CEIV Pharma)
Introduction
 
Quality Management
 
Personnel
 
Training
 
Documentation
 
Infrastructure and Equipment
 
Complaints and Quarantine
 
Supplier Management
 
Self-inspections & Internal Audits
 
Transportation
 
Operations
 
Total Module 5
 
Module 6: Temperature Controlled Containers
TCC Introduction
 
Limits, Ambient Conditions
 
TCC Charging
 
Pre-Conditioning
 
Cargo / Dry Ice Loading Guidelines
 
Container Handling Guidelines
 
Control Unit Operation Charging
 
Operation Modes, INFOS, Alerts and Alarms
 

Target Audience

Cargo / Ground Handling Operations Personnel (Quality / Senior Manager, Department / Section Manager, Product / Sales Manager, Training Manager, Customer Service & Ordering, Technical Support, Personnel Handling DG)

Pre-requisites

Good Command of English Language

Basic cargo operation, logistics, or supply chain 

Evaluation Mean(s)

Theoretical Examination at the end of the course.

Duration
10 DAYS
Price
Up on Request
Course Schedule

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