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This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
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  3. Thursday, 28 March 2013
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 (the video Nothing Stands Still can be viewed at 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 it has been possible to arrange only one such course a year. 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 2009. Besides providing 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. 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 the 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 You can also explore the very first example of this authentic e-learning course e-Pharmaceutical Cold Chain Management course at 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 analyse, report 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 ( Documents, records and record management by James Vesper 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 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 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 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 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 Management Extensio et Progressio: Authentic e-Learning

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