Qualified Person Training

  • Overview

Our flagship educational program is Qualified Person training, which we have been offering since the 1990s in partnership with the University of Strathclyde, one of the premier universities in the UK. This program is the most highly regarded Qualified Person education program available; NSF-trained QPs are well respected within the industry and their status is recognized across Europe as best in class.

The course consists of 12 modules held over 21 months and it is carefully designed to meet the requirements for theoretical training as detailed in EC Directives 2001/20/EC, 2001/82/EC and 2001/83/EC and in the latest Qualified Person Study Guide.

The modules provide practical, face-to-face tuition in master’s degree-level detail to prepare candidates for the challenging, demanding and ever-growing role of acting as a QP in today’s pharma industry. This course uniquely focuses on the knowledge and practical decision making exercises necessary to build the skills and confidence for the QP role. Sufficient time and depth are provided to grow QPs to be the best they possibly can be and to prepare the candidates for the role, not just the assessment.

We work with you to maximize the chance for success at viva or international assessment and beyond. We provide unparalleled support, from training plan development and gap analysis to a supportive tutor system, QP skills training, support with application and revision interview, and a strong alumni organization. Your chance of passing a QP assessment is higher with NSF than with any other provider.

Not everyone attending our QP modules wants to become a QP. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control. Others attend as part of their continuing professional development including postgraduate qualifications through our university affiliation. In fact, we train more individuals globally through courses at their own sites than we do through the QP modules at our site. The syllabus is seen as essential to all technical leaders, managers and supervisors working in the industry supporting product realization and release.

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  • Open What level of experience and knowledge would you recommend students have prior to attending the Effective Pharmaceutical Audit and Self Inspections course?

    Delegates who attend this course are expected to have relevant GMP and/or audit experience. Delegates are expected to have a working knowledge of EudraLex Volume 4, Chapters 1 – 9 or US 21 CFR Parts 210/211, and an awareness of ICH Q8, Q9 and Q10.

  • Open Is there a written exam in the Effective Pharmaceutical Audit and Self Inspections course?

    Yes. On the last day, there is a two-hour written examination. During the week of the course, time is spent working through an example paper and delegates are given the opportunity to have one and a half hours of exam preparation time before the exam. Delegates for whom English is a second language are allowed an extra 30 minutes for the exam.

  • Open I am a Qualified Person (QP) and I want to become an IRCA-registered auditor. How do I proceed?

    If you are interested in becoming an IRCA-certificated auditor, the first step is to attend our Effective Pharmaceutical Audits and Self-Inspections PQMS Auditor/Lead Auditor Course, A17638. Once you have passed the NSF course and exam, you will need to apply to IRCA for certification and fulfil their criteria. For more information, see www.irca.org.

  • Open Do I need to attend all the modules?

    No, unless you wish to aim for the postgraduate diploma or MSc, modules can be selected as required.

  • Open How can I decide which modules to attend?

    Delegates are offered a free gap analysis with a course tutor. Guidance can be given during a face-to-face interview or remotely after providing a detailed CV for review.

  • Open How long does the course take?

    This depends on how many modules the delegates wish to attend and where these fall in the series. A full series typically takes 18 months but some delegates prefer to spread the course over 2 series. Flexibility is the name of the game!

  • Open How do I enroll for the postgraduate certificate?

    Delegates should register their interest with their tutor and/or QP course administrator. The University of Strathclyde will be informed and will subsequently coordinate the qualification direct with the delegate. The requirements for the certificate are to attend three foundation modules and three of choice, perform satisfactorily in the module assessments, and sit the certificate exam at the university.

  • Open How do I enroll for the postgraduate diploma/MSc?

    The University of Strathclyde coordinates their qualification directly with the delegate. Typically the requirements for the diploma are to attend all modules, perform satisfactorily in the module assessments, and sit the diploma exams at the university.

    The MSc requires the above plus a workplace thesis/project, approved by the course director at the university.

  • Open I’ve heard about the personal tutor system, what is it?

    Delegates who attend four or more modules are classed as “core” delegates. This brings additional benefits to the delegate:

       
    • Core delegates are assigned a personal tutor who offers support and guidance through regular meetings on modules regarding the application process and experience requirements for the viva.
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    • Core delegates are also offered a free revision interview 6-8 weeks before their viva to assess the delegate’s readiness for the viva.
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    • Review of the QP application form prior to submitting to the Joint Professional Bodies.
  • Open Do all modules cost the same?

    No, some are five days in duration and some are four days. In addition different venues (such as the practical module in Glasgow) can impact on the course costs.

  • Open Once the series is finished do I still have use of your advice and consultancy?

    Yes. Past delegates on our courses are always welcome to contact us with comments or queries for opinion or advice. This is a free service and we are always pleased to keep in touch with past delegates.

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  • "NSF provided me with the most comprehensive QP training I could have hoped for. I can understand why the training is held in such high regard as the tutors’ delivery, experience and importantly their focus on personal development is exceptional."Ian Birch / Roche Pharma AG

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