What delegates have said about recent QP courses:
“A well put together course, with relevant group exercises that fitted very well with the lectures”
“Fast paced - and very enjoyable - real examples of issues applied to real-life situations!”
EU legislation requires medicinal products to be certified as complying with various
authorisations, national legislation and GMP. The legislation assigns personal
responsibility for these activities to a ‘Qualified Person’ and requires that every
manufacturing site (including those manufacturing investigational medicinal products) employs the services of such a person. Under the permanent provisions of the EU legislation (2001/83/EC) educational and experience criteria need to be fulfilled. In the UK this is ensured and administered by three professional bodies who publish a Study Guide against which trainee QPs are ultimately assessed by viva examination. Study is based around 11 subject areas, comprising 3 ‘Foundation’ modules and 8 ‘Additional Knowledge’ modules. The unique and flexible approach that RSSL take in providing training in this area has made it an increasingly popular choice for many companies and individuals alike.
Key Features
- Modules based on the latest ‘QP Study Guide’ Requirements, with the emphasis on case study and problem-based learning.
- Affordable courses lasting only two or three days, save on time away from the workplace
- Courses have a sound practical focus on the key elements and competencies needed to make sensible judgements and rational decisions.
- Choose to attend anything from a single module through to the full complement – you choose what is appropriate for your needs
- All 11 training modules are presented over a single calendar year, which means that you can schedule your study at a time convenient to you
- Experienced tutors include a number of current and former QP Assessors
- Courses are equally popular with existing QPs as part of their Continuous Professional Development (CPD)
Dates - 10th - 11th January 2012, 26th - 27th June 2012
Qualified Persons must have a comprehensive knowledge of EU Directives and UK Laws and Regulations to perform confidently and to be able to advise their company accurately. This module not only provides that knowledge but explains some of the complex jargon that can prevent a full understanding. The two days of fully interactive tutoring also covers MRAs, Pharmacopoeias and the MHRA and EMEA organisations.
Dates - 15th - 16th May 2012
A Qualified Person (QP) must certify that each batch of medicinal product complies with its Marketing Authorisation or Product Specification File, GMP and certain other requirements. Their conduct overall must comply with the Code of Practice for QPs. This module examines the responsibilities of a QP in depth, including case studies and questions that challenge the attendees’ knowledge of the Code and of the Guide to Good Manufacturing Practice.
Dates - 13th - 15th November 2012
It is a fundamental requirement of GMP that organisations design and implement a Quality Management System (QMS) that is appropriate for their activities, is fully documented and monitored to ensure effectiveness. Without an effective QMS the QP cannot be sure that systems remain in control and cannot be confident that each batch of product has been manufactured according to the requirements. It follows that the QP must be able to judge if the QMS is effective by understanding the feedback that it should provide. This course is designed to cover establishment, implementation, maintenance and effective operation of a QMS and is therefore key to all aspiring QPs, plus others working in both quality and operational roles. It will give practical guidance on all the major elements of a typical QMS.
Dates - 11th - 12th April 2012
The study guide emphasises that QPs must have a knowledge of the practical application of basic statistical tools in pharmaceutical production and QA. This knowledge is essential in demonstrating the capability of processes or the acceptability of materials. In particular QPs should be able to demonstrate an understanding of statistical process control, sampling and the statistics employed during method validation. This fully revised course focuses on establishing key learning points regarding the application of techniques rather than the techniques themselves. Presentations are supported by exercises or case studies to reinforce principles & best practices. In addition, the incorporation of ICH Q8, Q9 and Q10 into EU GMP will require QPs to be more able to understanding statistical tools and techniques as part of a Quality Management System involving quality by design and risk-based approaches.
Dates - 5th - 7th March 2012
Qualified Persons cannot fulfil their role in a responsible way unless they understand the actions and uses of the medicinal products they are asked to certify. Supported by the top subject matter experts from the University of Reading School of Pharmacy, this three day module takes major therapeutic categories as examples and together with some basic physiology, discusses the pharmacology of particular drugs used for those categories, before using case studies to explore the implications for the QP.
Dates - Part 1 11th - 13th June 2012, Part 2 9th - 11th July 2012
The Qualified Person should be the company expert in the formulation and processing of medicinal products they are asked to certify. This five day (2 part) module provides basic formulation principles, including preformulation studies, bioavailability considerations and the effect of excipients on physical and chemical stability. Each major product category is considered separately with respect to common formulations and processing techniques and the course includes many exercises of situations for the trainee QP to practise decision making.
Dates - 2nd - 3rd October 2012
The QP needs an understanding of the microbiological control of pharmaceutical
products. Delegates will discuss the main types and sources of micro-organisms and
the issues associated with them in relation to sterile and non-sterile pharmaceutical
production. Specific sessions cover water systems, clean room design and operation,
and the concept of sterilisation and sterility assurance.
Dates - 22nd - 24th October 2012 (includes practical day)
The sampling and testing of materials does not by itself assure product quality. It must be part of a comprehensive ‘Quality Management System’, including QA and GMP, which must be correctly implemented and controlled. This module includes GCLP, interpretation of analytical data and non-conforming results, the principal qualitative and quantitative analytical methods in common use, the principles of method selection and validation, sampling, physical and organoleptic testing, stability testing and the significance of degradation, contamination and adulteration of pharmaceutical materials.
Dates - 11th - 13th September 2012
The QP needs to fully understand the challenges and risks involved in packaging operations in the Pharmaceutical Industry. A significant percentage of all product related complaints and recalls are related to packaging. This course closely examines the key stages of pharmaceutical packaging relevant to the QP, from component manufacturers and suppliers to final product release including QP certification. It includes artwork control, labelling, (including braille), anti counterfeiting measures and packaging GMPs. It will give practical guidance on the major challenges and risks associated with packaging operations.
Dates - 7th - 8th February 2012
This course includes both the technical aspects of manufacturing Active Pharmaceutical Ingredients and the requirements of Good Manufacturing Practice. The Qualified Person is expected to formally certify that each API is manufactured to GMP and the training provided during the two day course will give the QP confidence in coming to a decision on whether to certify or not, or to ask for further information.
Dates - 8th December 2011, 4th December 2012
The QP needs to be aware of the different requirements between commercial and clinical trial operations. This is one day course examines EU legislation and GMP issues, many of which are unique, associated with Investigational Medicinal Products (IMPs). It will provide practical guidance on the major differences between IMPs and commercial operations. Delegates will also have the opportunity to learn about the principles of Good Clinical and Good Laboratory Practice. The course is ideally suited for those wishing to ensure they have sufficient awareness of the specific nature of IMPs and the challenges facing the QP.
Dates - 25th July 2012
The QP needs to understand the quality issues associated with the manufacture of biopharmaceuticals. Whilst the other modules cover biotechnology products alongside other product types, based around the study guide, this workshop is designed to pull together the information in a way that provides participants with a good overview of the quality and regulatory issues surrounding the development and production of biopharmaceuticals for global use.
Dates - 14th May 2012, 1st October 2012
These meetings provide you with opportunity to network in an informal environment; key tutors will briefly introduce controversial and current topics before encouraging you to increase your ‘argumentative muscle’ in small group discussions. Whilst they will remain on hand to facilitate and give their views if challenged, you will be the drivers of the pace and direction of the discussion. Invaluable for increasing your exposure to key issues before an impending Viva, these sessions are also great for continuous personal development or the place to find out what is really involved in becoming a QP. Please join us – the more the merrier and the better the debate!
Viva Preparation Sessions
Most QP candidates approach their viva with some trepidation because they do not know what will happen during the one hour or so of questioning. This one day personal tutorial explains to the candidate what will happen, how the viva will be conducted and examines in detail some of the common questions that are asked. Candidates are shown how simple questions develop into complex scenarios and how they should deal with them. Candidates will benefit most by arranging this programme approximately 4 – 6 weeks before their viva date.