Recently, we were appointed by Bespak, a leading UK-based developer and manufacturer of complex medical devices, to provide GMP inspection readiness training ahead of their MHRA and FDA audits.
Bespak supply respiratory drug delivery devices, valves and actuators, injectable devices and medical check valves into major European and US markets. Each year they assemble around 550 million devices, and every second, over 1,000 patients use one of their devices to help them breathe.
When manufacturing life-saving devices like these, it is essential that Bespak are fully compliant and inspection ready, in order to ensure that their quality systems and operations can deliver devices to help millions of patients each year.
Quality Context were appointed to provide a two day training course for over 20 delegates, to help them prepare and plan for their regulatory inspections and show them how to really impress the MHRA inspectors and FDA investigators.
The purpose of the training was to:
- Give an overview of the MHRA and FDA and highlight the key differences in legislation and the agencies’ different approaches to inspections.
- Prepare the trainees on what to expect before, during and after the inspection.
- Review current FDA hot topics.
- Learn how to measure their inspection readiness.
- Run through and practice mock inspection questions and scenarios.
We pride ourselves on providing bespoke training that is extremely relevant to our clients. We believe that off-the-shelf training isn’t nearly as effective. We want our attendees to leave with ideas and knowledge that are ready to be implemented within their company’s processes.
After delivery of training we always ask our delegates for feedback. The feedback we receive really makes a difference to the way we provide training in the future. Bespak provided us with extensive positive feedback, which from our side, was obviously delightful to read. People really enjoyed the training and took a lot from the two days.
The feedback scored us at an average of 9 out of 10 for the following:
- Clearly defined objectives
- Relevancy of training exercises
- Flow of the training content
- Training engagement
- Knowledge of the trainer
- Attitude of the trainer
In addition, qualitative feedback highlighted that we exceeded expectations and that the delegates enjoyed the training much more than they expected to. They also commented that the training content was clear and concise, engaging and relevant.
Speaking about the training, David Preston, Operational Quality Manager at Bespak, said: “I had worked with Quality Context in a previous role and wanted to use them at my current company. Their attitude and responsiveness to our needs was excellent.
Quality Context really understood our company and tailored a training package that was interactive, fun, relevant and full of thought provoking, real life insights. My team were really impressed with the training content and delivery. I couldn’t be happier with their service quality and I would definitely work with them again in the future.”