Over a period of five years, learning groups composed of
fifteen participants and three mentors have traveled along the route of the
cold chain in Turkey. Public and private institutions hosted the learners
and allowed them to experience the real life of the cold chain.
Nothing Stands Still - Pharmaceutical cold chain management on wheels 2008 from EPELA on Vimeo.
The WHO-PDA Pharmaceutical Cold Chain management on
Wheels course has proven a notably intense and successful if not unique
learning experience. However, a week-long course required an
enormous amount of planning and resources – the reason why only one such course
a year has been possible to arrange. With the demand growing, we have
been challenged to find ways to provide a similar learning experience for the
cold chain practitioners around the world.
With the goal of increasing access to efficient learning
opportunities, the course design team was put together in late 2010.
Besides providing an important and useful content, the design team was
committed to create a unique technology-supported learning experience where
people could learn with and from each other and where real-life situations and
study cases could be used to develop expertise. The team also wanted to
include aspects of “authentic learning” where the learners could address real,
ill-defined problems and create solutions that would be of a real public health
benefit.
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25
September 2010, Antalya, Turkey (photo: Hakan Gonendik)
Design
team (from left to right) Umit Kartoglu, Thomas Reeves, James Vesper, and Gokhan
Gurses discussing the course objectives
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The e-Pharmaceutical Cold Chain Management course is
the result of the work of the talented and dedicated design team, including
instructional designers, illustrators, filmmakers, software engineers,
programmers, content experts, and formative evaluators who spent literally
thousands of hours on this project. Their motivation was driven by an
aspiration to create a high-quality learning programme that will help to assure
using time-temperature sensitive products that are safe, pure, and effective.
The platform EPELA (Extensio et Progressio: Authentic
e-Learning) provides all necessary tools to participants. EPELA
e-learning promotes collaborative learning which is now well recognized as the
vital aspects of effective learning and professional development. EPELA
e-learning enhances quality and outcomes of the courses offered. As good
as the other courses are, EPELA e-learning provides unique affordances for
supporting learning that even best traditional face-to-face courses cannot
match.
The EPELA e-learning platform can be visited at www.epela.net. You can also explore the
very first example of this authentic e-learning course e-Pharmaceutical Cold
Chain Management course at http://epela.net/epela_web/introduction.html.
The course takes participants inside an enhanced, robust mental model of a
pharmaceutical cold chain. For 11 weeks, we travel with participants
virtually from one location to another, through different levels of the supply
chain. In addition to the virtual visits to facilities, we offer short
illustrated videos and critical reference materials. Authentic tasks are
arranged mainly as group activities to promote collaborative learning and
enhanced with peer-review. The course site offers participants tools to
help to easily connect with other participants, discuss and produce as a
team. Mentors provide timely feedback to all participants whenever
necessary and are always ready to assist them whenever participants need
them. Following 7 weeks of virtual visits to facilities, participants are
introduced as a group to a real client so that together with their peers they
could analyze, repot and give recommendations to the client regarding the
client’s operation of the time and temperature sensitive pharmaceutical
products.
Although developed to support the authentic context of the
e-Pharmaceutical Cold Chain Management course, we make all short video-lectures
and limited number of documents publicly available (more documents are
available for course participants as well as facility tour videos, 360 degree
spherical and cylindrical photography of the facilities and authentic task
videos).
Both WHO and EPELA encourage others to widely use the videos
and embed them in other web sites. The following videos are now available
publicly (http://epela.net/epela_web/video_library.html):
Documents, records and record management by James
Vesper
Documents, records and records management - James Vesper from EPELA on Vimeo.
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.
Exploitation
of stability data to reach the unreached by Umit Kartoglu
Umit Kartoglu presents the
critical aspect of exploitation of stability data to reach the unreached
through overview of studies taking vaccines beyond the 8oC, 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.
Global Perspectives in Regulatory Oversight by
Rafik Bishara
Global Perspectives in Regulatory Oversight - Rafik Bishara from EPELA on Vimeo.
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.
How Best
to Use Stability Data for Handling of Time and Temperature Sensitive Products by Claude Ammann
How Best to Use Stability Data for Handling of Time and Temperature Sensitive Products - Claude Ammann from EPELA on Vimeo.
Claude Ammann reviews the importance of understanding regulations related to the stability testing to add value to evaluate temperature excursions.
Introduction to Quality Risk Management by James
Vesper
An introduction to quality risk management - James Vesper from EPELA on Vimeo.
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.
Last Mile by Umit Kartoglu
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.
Packaging
design by Kevin O'Donnell
Kevin O’Donnell
reviews the peculiarities of five different packaging technology: Nylon, EPS,
EPP, Airliner and VIP.
Risk
assessment methods by
James Vesper
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.
Storage Facility Design: Cold Storage by Andrew
Garnett
Storage facility design / Cold storage - Andrew Garnett from EPELA on Vimeo.
Andrew Garnett reviews the cold storage aspects of storage
facility design and covers temperature controlled storage areas, order assembly
areas and materials handling.
Storage Facility Design: Site and Buildings by
Andrew Garnett
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.
Thermodynamics by Kevin O'Donnell
Kevin O’Donnell discusses thermodynamics, the basis of heat transfer and how we can use heat energy to our benefit in packaging.
In addition these
illustrated video-lectures, EPELA also brings the following videos on technical
issues:
Five
senses: Vaccine Vial Monitors by World Health Organization
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.
Nothing stands still by World Health Organization
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.
Now is the time by Project Optimize
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.
Shake
and Tell (video article) by World
Health Organization
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.
Step-by-step
how to conduct the shake test by World Health Organization
This educational
video provides the steps of a standard validated way of performing a shake test
and interpreting the results.
WHO and EPELA, with the launch of their second course e-VVM
Based Vaccine Management, will make seven more illustrated-lecture videos
publicly available in coming months.
Stay tuned… With warmest regards,
Umit Kartoglu
Global Learning Opportunities for Vaccine Quality
Extensio et Progressio: Authentic e-Learning
Very good blog. Thanks for sharing the information design of cold storage
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