Customer Case Studies of Team Training Solutions

We can create a training programme on any topic, delivered in any format. Below are a few examples of solutions we have developed for our customers. We appreciate that every customer and their situation is unique. As a result, we design and deliver programmes that factor in your specific requirements to ensure your learning and business objectives are met.

Medical Device Customer Case Studies 

Case Study 1 | Medical Device Regulatory Affairs Training for a Pharmaceutical Consultancy

Scenario

There are a growing number of drug device combination products entering the market. Accelerated by advances in biotech and cell & gene therapies. Often a device is required to deliver the therapeutic medicinal product. This was the case for an Educo customer, a regulatory affairs consultancy business. Several of their clients had combination products in their portfolio using devices such as inhalers. They felt there was a gap in their knowledge when it came to the latest device requirements.

Training Need

The Educo customer required a high-level overview of the medical device roadmap to bring a device to market. This included topics such as risk management, design process, useability. They also wanted the latest MDR requirements, CE marking and UKCA marking. The team were also all working from home and the training needed to bring them together easily and cost effectively. In addition, they wanted a solution that could be used for their team as it continued to grow throughout the year.

Educo Life Sciences Solution

Educo created a live online training programme delivered as bitesize sessions. The equivalent of 2-days of training was delivered over four half days. Being online the whole team could join from anywhere in the country. The bitesize element meant it caused minimal impact on day-to-day work. The course provided a high-level overview of medical device regulations and included a workshop activity which got the team working together. All the sessions were recorded and uploaded to the Educo Training Portal, where on-demand course was built. The course remains available to the team and new employees are enrolled regularly.

Outcome

The Educo solution helped the customer understand the latest medical device requirements in the EU and UK. The team are also able to use the recordings as reference material as and when needed. This is very beneficial as a consultancy business working with varied clients. Although virtual, it also helped the team grow and develop together.

ATMP | Cell and Gene Therapy Customer Case Studies

Case Study 1 | Cell and Gene Therapy On-Demand Micro Learning

Scenario

Recently the life sciences industry has seen many developments within Cell & Gene therapies (CGT). With increasing success, the industry is receiving significant investment. In line with this an Educo client, a leading international life science company, had made several acquisitions within the advanced therapy space. Alongside incorporating these new businesses, the organisation also wanted to further invest and dedicate employee resources to focus on growing the Cell and Gene field.

Training Need

The client wanted to ensure they were best placed to efficiently distribute personnel resources onto new projects within CGT to ensure effective management and improve their chances of success. They were bringing onboard many new employees from outside the organisation and internally; all of which had a different understanding of CGT/ ATMPs. For this reason, it was crucial that they had a training that ensured a common understanding of ATMPs, the basics, an overview of their regulatory and quality challenges and the clients internal processes and interpretations.

Educo Life Sciences Solution

Educo created an online, on-demand micro learning course incorporating the client’s internal processes, jargon and interpretations. Held on Educo’s LMS the training material was made of short videos, reading materials, quizzes and games to ensure an engaging approach. Individuals were given a unique log in and able to access the material at any time and location with internet. The course recorded progress so individuals could dip in and out of the training around their busy schedules. Reports of completion and activity were provided by Educo to the client’s stakeholders so they could ensure the progression of the group.

Outcome

The Educo solution enabled the client to ensure a standardised basis of knowledge for all new employees joining CGT projects so that individuals came up to speed in a fast and effective manner, enabling them to immediately contribute to projects. The format of the training also ensured an easy administration for the client and minimal impact on day-to-day roles.

Case Study 2 | Navigating the Regulations for a Gene Therapy Product

Scenario

An Educo client, a biotech start-up, had raised a significant amount of funding to support the advancement of their innovative delivery mechanism for their gene therapy therapeutics. Their pipeline contained therapeutics for the treatment of rare and severe diseases.

Training Need

The Educo client’s need for training was threefold. Firstly, their modality is a very novel so there are currently no industry examples which their technical and R&D teams could use as a framework. Secondly, there was a lack of CTD writing experience within the different teams, so they needed to improve their understanding of EMA and FDA requirements. Thirdly, the regulations for their novel modality-based therapeutic is a grey area. It was either classified as a cell & gene therapy or biologic. The client wanted their R&D teams to receive a recurring training course focused on early development.

Educo Life Sciences Solution

Educo Life Sciences created a comprehensive and customised on-site training workshop built around the client’s objectives, processes and modalities, delivered on-site at client’s premises. For the workshop the analytical and process teams worked together to conduct two joint mock exercises to assess and design process change comparability studies and method tech transfers.

Outcome

The Educo solution enabled the client to ensure an aligned level of knowledge across their analytical and process teams for early development, becoming well-versed in Regulatory requirements and interpreting guidance documents, and successfully contributing to the advancement of the client’s novel modality-based therapeutics pipeline.

Pharmaceutical Regulatory Affairs Customer Case Studies

Case Study 1 | Medical Device Regulatory Affairs Training for a Pharmaceutical Consultancy

Scenario

There are a growing number of drug device combination products entering the market. Accelerated by advances in biotech and cell & gene therapies. Often a device is required to deliver the therapeutic medicinal product. This was the case for an Educo customer, a regulatory affairs consultancy business. Several of their clients had combination products in their portfolio using devices such as inhalers. They felt there was a gap in their knowledge when it came to the latest device requirements.

Training Need

The Educo customer required a high-level overview of the medical device roadmap to bring a device to market. This included topics such as risk management, design process, useability. They also wanted the latest MDR requirements, CE marking and UKCA marking. The team were also all working from home and the training needed to bring them together easily and cost effectively. In addition, they wanted a solution that could be used for their team as it continued to grow throughout the year.

Educo Life Sciences Solution

Educo created a live online training programme delivered as bitesize sessions. The equivalent of 2-days of training was delivered over four half days. Being online the whole team could join from anywhere in the country. The bitesize element meant it caused minimal impact on day-to-day work. The course provided a high-level overview of medical device regulations and included a workshop activity which got the team working together. All the sessions were recorded and uploaded to the Educo Training Portal, where on-demand course was built. The course remains available to the team and new employees are enrolled regularly.

Outcome

The Educo solution helped the customer understand the latest medical device requirements in the EU and UK. The team are also able to use the recordings as reference material as and when needed. This is very beneficial as a consultancy business working with varied clients. Although virtual, it also helped the team grow and develop together.

Biotech Customer Case Studies

Case Study 1 | Cell and Gene Therapy On-Demand Micro Learning

Scenario

Recently the life sciences industry has seen many developments within Cell & Gene therapies (CGT). With increasing success, the industry is receiving significant investment. In line with this an Educo client, a leading international life science company, had made several acquisitions within the advanced therapy space. Alongside incorporating these new businesses, the organisation also wanted to further invest and dedicate employee resources to focus on growing the Cell and Gene field.

Training Need

The client wanted to ensure they were best placed to efficiently distribute personnel resources onto new projects within CGT to ensure effective management and improve their chances of success. They were bringing onboard many new employees from outside the organisation and internally; all of which had a different understanding of CGT/ ATMPs. For this reason, it was crucial that they had a training that ensured a common understanding of ATMPs, the basics, an overview of their regulatory and quality challenges and the clients internal processes and interpretations.

Educo Life Sciences Solution

Educo created an online, on-demand micro learning course incorporating the client’s internal processes, jargon and interpretations. Held on Educo’s LMS the training material was made of short videos, reading materials, quizzes and games to ensure an engaging approach. Individuals were given a unique log in and able to access the material at any time and location with internet. The course recorded progress so individuals could dip in and out of the training around their busy schedules. Reports of completion and activity were provided by Educo to the client’s stakeholders so they could ensure the progression of the group.

Outcome

The Educo solution enabled the client to ensure a standardised basis of knowledge for all new employees joining CGT projects so that individuals came up to speed in a fast and effective manner, enabling them to immediately contribute to projects. The format of the training also ensured an easy administration for the client and minimal impact on day-to-day roles.

Case Study 2 | Navigating the Regulations for a Gene Therapy Product

Scenario

An Educo client, a biotech start-up, had raised a significant amount of funding to support the advancement of their innovative delivery mechanism for their gene therapy therapeutics. Their pipeline contained therapeutics for the treatment of rare and severe diseases.

Training Need

The Educo client’s need for training was threefold. Firstly, their modality is a very novel so there are currently no industry examples which their technical and R&D teams could use as a framework. Secondly, there was a lack of CTD writing experience within the different teams, so they needed to improve their understanding of EMA and FDA requirements. Thirdly, the regulations for their novel modality-based therapeutic is a grey area. It was either classified as a cell & gene therapy or biologic. The client wanted their R&D teams to receive a recurring training course focused on early development.

Educo Life Sciences Solution

Educo Life Sciences created a comprehensive and customised on-site training workshop built around the client’s objectives, processes and modalities, delivered on-site at client’s premises. For the workshop the analytical and process teams worked together to conduct two joint mock exercises to assess and design process change comparability studies and method tech transfers.

Outcome

The Educo solution enabled the client to ensure an aligned level of knowledge across their analytical and process teams for early development, becoming well-versed in Regulatory requirements and interpreting guidance documents, and successfully contributing to the advancement of the client’s novel modality-based therapeutics pipeline.

Team Training Customers

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