Q&A: Qualified Person Training

  • 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.

  • Open What is the success rate of your delegates at viva?

    Information to date shows a pass rate of 96% for delegates we have trained.

  • Open Is there an exam for each module?

    Yes, the exams usually take place prior to the next module, on Sunday evening at 6:30. Some modules however are assessed by dissertation and a deadline provided for submission.

  • Open I don’t want to be a QP but this looks like great training, can I attend?

    Yes. Not everyone attending the modules is looking to become a QP. Many use the training to develop as technical managers or as part of their continuing professional development.

  • Open Do I need a sponsor?

    Ideally a QP and someone who knows you and your roles and responsibilities well. Someone who can provide you with ongoing support through your training. Your sponsor will be required to complete a sponsor’s report to accompany your QP application form. NSF encourage sponsors to visit a module and meet the personal tutor to check on progress.

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