RSSL have been running courses for trainee QPs for over 15 years, with an unsurpassed first time viva pass rate (>90%). All tutors are experienced quality professionals (mostly current practicing QPs), with significant subject matter expertise, who have spent significant time in the ‘real’ world. RSSL courses are also supported by the academic excellence of Professors and Lecturers from the University of Reading. 

Reinforced by on line WebTorials and guided self study, the RSSL QP programme is classroom based in our new training facilities on the University of Reading campus. Behind the scenes a team of professional training staff are dedicated to helping candidates on the journey to gaining QP eligibility, and welcome the opportunity to meet and work with Sponsors. We offer CV Gap Analysis, an individually designed Training Plan and a ‘Personal Coach’ assigned to continuously monitor and review progress. Towards the end of training we provide guidance on completing the Viva Application Form, and an individual ‘Viva Readiness’ day with a Lead QP Tutor, to demystify the process and fully prepare the candidate.

QP ROLE AND CAREER PATH

ROLE AND RESPONSIBILITIES

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).

The requirement for a 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 Royal 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 a QP. Ensuring compliance with these conditions is the responsibility of the Competent Authorities of the Member States.

There are also wider technical, ethical and professional obligations in terms of patient safety, quality and efficacy to be considered. Thus in order to become eligible to act as a QP, candidates 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

RSSL QP CAREER PATH PROGRAMME

Your personal 'QP Career Path Programme' is run by expert tutors and a full team of professional training staff, all dedicated to supporting your QP career path and offering

  • CV gap analysis
  • Individually designed training plans
  • Classroom based training
  • Online WebTorials and CPD Days
  • Guided self study
  • A'Personal Coach' assigned to continuously monitor and review progress
  • Guidance on successfully completing your viva application form
  • 1:2:1 'Viva Readiness' sessions with our lead QP tutor
  • Opportunity to meet and work with your sponsor

QP Training Modules


FREE QP Seminar - To QP or not to QP.. That is the Question?

A FREE seminar for the Pharmaceutical Industry, to learn about the role of the Qualified Person (QP) and Sponsor.

Our QP Roadshows explore what is involved in becoming a Qualified Person (QP), discussing the level of commitment expected of a QP, what you can expect from the RSSL training programme and the assessment process.

2017 Dates: 10 July, 23 November

Find out more

Why QPs train with RSSL:

  • Unbeaten first time pass rates at ‘viva’
  • 11 modules tailored specifically to the Study Guide, all accredited by the RSC
  • Short duration (2 or 3 days) – less time away from the workplace, less outlay on fees and accommodation
  • Each module ‘self-contained’ and scheduled twice yearly, allowing you to join at any time
  • Interactive problem based training, in small groups, designed to maximise learning
  • All tutors are current industry subject matter experts, with 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
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