· 8 min read
NSF is the recognized leader in the training of Qualified Persons (QPs). Over many years, our tutors have trained and mentored QP students. In this video and article, Catherine Kay from NSF looks at the requirements that prospective QPs need to consider and what to expect from QP training with NSF.
A QP is a qualified person, and within the UK and the EU, the primary legal responsibility of a QP is to certify batches of medicinal product prior to use in a clinical trial or prior to release for sale onto the market. All the requirements and functions of the QP are detailed in the UK statutory instruments, as well as the EU Directives. To become a QP you need to be a member of one of the professional bodies and within the UK there are three professional bodies.
The Royal Pharmaceutical Society, the Royal Society of Biology and the Royal Society of Chemistry are collectively known as the joint professional bodies. To become a member, you need to have the appropriate qualifications, which typically is a science degree. You also need to have a minimum of two years’ experience working on a site that's licenced to manufacture medicinal products. You will need to demonstrate that you have a thorough understanding of all of the knowledge elements as described in the QP study guide.
The QP Study Guide is written and developed by the joint professional bodies. The assessment is carried out through an oral examination, so this is a Viva and once you've successfully completed the Viva you are then eligible to act as a qualified person and you can be named on the manufacturing licence by the MHRA. Our training at NSF meets the requirements of the QP Study Guide and the content is also at MSc level. Our courses are delivered by expert tutors who are QPs and have many years of industry experience as well as expert academics from the University of Strathclyde. The training is delivered using case studies and real-life scenarios to maximise learning.
To help you decide which modules to take, we offer a free gap analysis service with one of our course experts. Depending on your qualifications and experience, you don't necessarily need to attend all the modules. However, we will advise you on this, unless of course you want to take the postgraduate qualifications with the University of Strathclyde. You can attend our training courses several different ways. You can either attend in person at a hotel-based venue in the UK with our experts, or you can attend the course virtually.
We deliver virtual training through a blend of self-paced learning that you access on our Learning Management System as well as virtual instructor led training with our experts. These instructor led classrooms are focused and interactive, using polls, whiteboard chat and team work in virtual breakout rooms. They have been designed to ensure full participation and to maximise learning. For our in person training, we also have the opportunity to carry out some site visits to see State-of-the-art facilities within the UK. The time it takes to complete the course depends on the modules that you wish to take, and this also depends on your prior experience.
This can be completed in twelve months, but typically our trainees take two to three years to suit their work schedule. Whether you are a UK EU or international student. You can enroll for the Postgraduate certificate, Diploma or MSc directly with the University of Strathclyde. However, you must complete the training courses with us and pass the end of module assessments. We offer a personal tutor service for those attending six or more modules with us.
Your tutor will offer support and guidance through your QP journey through regular meetings. This will also include viva preparation sessions, a review of your QP application form, as well as a revision interview to assess your readiness for the viva. Your relationship with NSF does not stop when you complete your training with us. We're always pleased to keep in touch, and you can contact us for advice or for any queries. Not everyone attending our training modules wants to go on to become a qualified person.
Many people join our training to develop as technical managers in other areas of pharmaceutical manufacture and control. Others attend as part of their continuing professional development. Our syllabus is seen as essential skills training for leaders, managers, and team leaders in the pharmaceutical industry.