Video
Library
extensio et progressio / authentic e-learning
e-Pharmaceutical Cold Chain Management Course
Mentors
Ümit Kartoglu
James Vesper
Kevin O’Donnell
Andrew Garnett
Who
said what
Credits
Team Credits
Video Credits
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online
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Introduction
Video
Learning
Objectives
Programme
Document
Library
Video
Library
Documents, records and record management
James Vesper reviews the critical aspects of documents, records and record management. Documents like procedures, protocols, methods, and specifications provide instructions so people can perform tasks and make decisions safely, effectively, compliantly, and consistently. Records, such as batch manufacturing records, cleaning logs, and laboratory data sheets and notebooks provide evidence that actions were taken and decisions were (hopefully) made in keeping with procedures and GMP expectations. Reports, another type of documentation, provide specific information on a particular topic (like an investigation or one aspect of product development) in a formal, standardized way.
James Vesper
Exploitation of stability data to reach the unreached
Umit Kartoglu presents the critical aspect of exploitation of stability data to reach the unreached through overview of studies taking vaccines beyond the 8 deg C all published in peer-review journals as well as a new concept of cool water packs by the WHO and Vaccine Vial Monitors. As he indicates that vaccines have become more stable and there is a clear prospect of increased or even complete heat stability, and concludes that in these circumstances the dogmatic approach to the cold chain causes resources to be wasted and places unnecessary restrictions on field operations.
Ümit Kartoğlu
Five senses: Vaccine Vial Monitors
A movie, produced for the 10th year anniversary of the introduction of vaccine vial monitors (VVM). The movie focuses on how this simple tool expands the horizon of the immunization programme and empowers health workers serving people at the very periphery of the health system. The theme and the goal are specific but there are scenes, human conditions, different livings for everybody to see and think about them. Shot in Niger, Vietnam and Indonesia in 2007.
World Health Organization
Global Perspectives in Regulatory Oversight
Members of the pharmaceutical supply chain have various global requirements to meet during the storage, transport and handling of time and temperature-sensitive products. Changing product portfolios, requirements for good storage and distribution practices, regulatory expectations, quality management, and risk assessment factors bring many challenges to the handling of drug products. Rafik Bishara reviews the global perspectives in regulatory oversight on pharmaceutical time and temperature products.
Rafik Bishara
How Best to Use Stability Data for Handling of Time and Temperature Sensitive Products
Claude Ammann reviews the importance of understanding regulations related to the stability testing to add value to evaluate temperature excursions.
Claude Ammann
How to use the Fridge-tag®
A technical instructional video on how to use Fridge-tag® for temperature monitoring in refrigerators.
World Health Organization
How to use the Q-tag2 plus®
A technical instructional video on how to use Q-tag2 plus® for temperature monitoring in international shipments.
World Health Organization
How to use Vaxalert®
A technical instructional video on how to use Vaxalert® for temperature monitoring in international shipments.
World Health Organization
Introduction to Quality Risk Management
Risk management involves a series of activities that are sequenced so that one step informs or shapes those that follow. James Vesper provides a high-level overview of the entire process.
James Vesper
Last Mile
Umit Kartoglu reviews the critical last mile between the service point and the end user. He further discusses the best solutions for storage and transport of products and best practices for temperature monitoring.
Ümit Kartoğlu
Nothing stands still
The video of the WHO-PDA Pharmaceutical cold chain management on wheels course conducted during 2-7 June 2008 in Istanbul, Ankara, Konya, Eskisehir and Bursa (1,400 km route) in Turkey.
World Health Organization
Now is the time
This three-minute video examines the growing challenges of maintaining reliable vaccine supply and logistics systems and offers potential solutions toward achieving optimized, efficient systems that reach people with the vaccines they need.
Project Optimize
Packaging design
Kevin O’Donnell reviews the peculiarities of five different packaging technology: Nylon, EPS, EPP, Airliner and VIP.
Kevin O'Donnell
Risk assessment methods
James Vesper goes into details of methods frequently used in risk assessments and gives first hand advise on when and how best to them: Preliminary risk assessment, failure mode effects analysis and fault tree analysis.
James Vesper
Shake and Tell (video article)
This is the first ever video of a full-fledged scientific article on the validity of the shake test. Shake test is the only test available to diagnose whether a freeze-sensitive vaccine has been damaged by freezing.
World Health Organization
Step-by-step how to conduct the shake test
This educational video provides the steps of a standard validated way of performing a shake test and interpreting the results.
World Health Organization
Storage Facility Design: Cold Storage
Andrew Garnett reviews the cold storage aspects of storage facility design and covers temperature controlled storage areas, order assembly areas and materials handling.
Andrew Garnett
Storage Facility Design: Site and Buildings
Andrew Garnett reviews the storage facility design with a particular emphasis on the site and buildings through analysing the reasons for storing cold chain products, different types and functions of storage facilities, location, access, security, general building design issues.
Andrew Garnett
Thermodynamics
Kevin O’Donnell discusses thermodynamics, the basis of heat transfer and how we can use heat energy to our benefit in packaging.
Kevin O'Donnell
