Qualified Person Training

Approved by the CQI and RSC, our modular programme is the most flexible choice for your QP training:

Our QP training courses are carefully designed to focus on the knowledge requirements detailed in the latest Joint Professional Bodies Study Guide. Find out more about the individual modules, and about what makes them unique.

The benefits:

  • Tailored specifically to the Study Guide
  • Unbeaten first time pass rates at ‘viva’
  • Flexible and cost-effective to suit your individual needs
    • Short duration [2 or 3 days] - less time away from the workplace, less outlay on course fees and accommodation
    • Each module scheduled twice a year - never miss a module because of an inspection!
    • Each module ‘self-contained’ allowing you join at any time, mixing and matching according to your experience
  • Top Tutors
    • Current industry subject matter experts ensure a pragmatic approach
    • Practicing QPs support every module
    • Current professional body ‘Assessors’ mean you know what to expect at ‘viva’!
    • Leading academics from University of Reading add support to our programmes
  • Support at every stage of your journey
    • Gap analysis of your CV to help design your individual training plan
    • Review of your viva application form
    • 1:2:1 personal coaching with our ‘viva readiness’ days
    • on line ‘Hot Topic WebTorials’ for revision and CPD

The concept of the Qualified Person (QP), first established in 1975, is a unique regulatory requirement that applies only within the European Union (EU). The only comparable situation exists within Member States of the European Economic Area (EEA) with whom the EU has reciprocal agreements. Each holder of an Authorisation to Manufacture products for use in a Clinical Trial or products subject to Marketing Authorisations, within Member States of the EU, must name a person or persons eligible to act in the capacity of QP. This QP has the legal responsibility for certifying batches of Medicinal Product prior to use in a Clinical Trial (Human Medicinal Products only) or prior to release for sale and placing on the market (Human and Veterinary Medicinal Products).

The requirement for QP covers both Human and Veterinary Medicinal Products including those intended for export. The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK Department of Health, and the Veterinary Medicines Directorate (VMD), have interpreted the requirements of the Pharmaceutical Directive 2001/83/EC and the Veterinary Directive 2001/82/EC through a Study Guide, drawn up by a panel of experts, and have given authority to three professional bodies - the Society of Biology, the Royal Pharmaceutical Society and the Royal Society of Chemistry - to operate an assessment procedure for their members. The assessments seek to determine an applicant's suitability for being named on a company Manufacturer’s Licence as QP. Ensuring compliance with these conditions is the responsibility of the Competent Authorities of the Member States.

Before you embark upon becoming a Qualified Person, you should understand what the role of the QP is and the requirements for eligibility.

The primary legal responsibility of the QP is to certify batches of Medicinal Product prior to use in a Clinical Trial (Human Medicinal Products only) or prior to release for sale and placing on the market (Human and Veterinary Medicinal Products). However, the wider technical, ethical and professional obligations in terms of patient safety, quality and efficacy must also be considered.

In order to become eligible to act as a QP, candidates will need to demonstrate:

  • The relevant practical experience in one or more licensed facilities
  • An in-depth working knowledge and understanding, allied to practical experience
  • A thorough understanding of the principles and requirements laid out in "the Orange Guide"
  • An ability to translate those principles and requirements to other situations currently outside his or her direct experience
  • An endorsement of his or her credentials, including qualifications and experience, from a sponsor

Each Qualified Person training module is specifically designed to focus on one of the subjects most important for an aspiring QP. A choice of two dates each year is available for every individual module.

There is no formal acceptance criteria for attending any of the training modules; however, we do refer potential QP delegates to the pre-requisites set out in the Joint Professional Bodies Study Guide.

Continuing Professional Development (CPD) - our range of CPD activities complement our training courses and allow attendees to maintain and enhance their knowledge and skills related to their professional roles. These include our very popular one day course which covers a range of areas as well as our specific WebTorials to discuss current hot topics within the pharmaceutical industry. 

Bookings

To make a booking or discuss any aspect of our training courses, contact our Customer Service Team:

t: +44 (0)118 918 4076
e: enquiries@rssl.com

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