An NSF International Company Qualified Person Training
U.K and Europe
- About QP Training
- QP Training Modules
- Evening Sessions
- What you've said
- Role of Honour
- FAQs
- Useful Links
We have been running Qualified Person (QP) training courses since 1990 and they are generally considered to be the best available – our QPs are very highly regarded within the industry and their status is recognised by many other countries including Ireland, The Netherlands, Austria, Hungary and Malta.
The course provides practical, face-to-face tuition in sufficient depth to prepare you fully for the challenges ahead. The plain fact is that you are more likely to become a QP with us than with any other training provider.
The Aspiring Quality Leader and the Technical Professional
We run a series of 12 modules held over 21 months, a course carefully designed to meet the requirements for theoretical training as detailed in EC Directives 2001/82/EC and 2001/83/EC and in the latest UK Qualified Person Study Guide.
Not everyone attending wants to become a QP. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control. Others attend as part of their continuing professional development including Postgraduate Qualifications.
What We Offer
- In-depth, face-to-face instruction from seasoned professionals.
- The University lecturers are acknowledged experts in their field
- All the NSF Health Sciences tutors are eligible to act as QPs; many are current or former QP assessors and several are ex-UK medicines inspectors
- All students attending most or all of the modules will be assigned a personal tutor to provide advice and support throughout their training period
Flexibility to Meet YOUR Individual Demands
- You can join and leave our series of modules whenever you choose, you do not have to start on the first and finish on the last
- You will have the opportunity to gain a Postgraduate Qualification in Pharmaceutical Quality and Good Manufacturing Practice
- We will be happy to assess your needs and advise you which modules to take
Free Management Skills Seminars
- NSF Health Sciences partners with specialists in this area to ensure you receive the best training and support
- Designed to help you develop the managerial skills to complement your technical knowledge
Unsurpassed Success Rate
- Over 95% of our students are successful at QP interview
- In recent years, more people have gained QP status with us than with all the other training providers put together
QP Training Modules
Twelve linked, but stand-alone training modules make up the complete series of Qualified Person and Professional Development Training.
The series spans 21 months and is repeated every 2 years, but don’t worry if you missed the beginning of the current series - you can join and leave at any point.
PLEASE NOTE: All of these training modules are offered as potential in-house training courses. Several companies have elected to train their staff via a series of in-house modules, perhaps combined with the residential modules, in order to speed up the training process.
Our new Series 13 QP brochure is now available. The new series of QP training runs from October 2014 through to September 2016. Please click the link below for further information or to download a copy of the brochure.
- Pharmaceutical Law & Administration
- Medicinal Chemistry & Therapeutics
- Formulation & Processing
- Pharmaceutical Microbiology
- Active Pharmaceutical Ingredients
- Mathematics & Statistics
- Analysis & Testing
- Pharmaceutical Packaging
- Quality Management Systems
- Practical Module
- Investigational Medicinal Products
- Role & Professional Duties of the QP
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Pharmaceutical Law & Administration
Pharmaceutical law and administration is a key foundation knowledge requirement for all Qualified Persons (QPs). This is clearly spelled out in the relevant article of European Directives 2001/82/EC and 2001/83/EC and in the current UK Qualified Person Study Guide. The QP must ensure that the relevant laws are being complied with. Thus, a thorough understanding of the laws and legal processes, within Europe and beyond, is essential. This is equally true for other pharmaceutical technical managers.
This extremely popular module is designed to ensure that, in an increasingly changing world, you have a deep and detailed understanding of…
- Why we have medicines laws and what they seek to achieve
- The laws and legislative processes within the EU which impact on medicinal products, and hence the role of the QP
- The UK Medicines Act and legislative framework
- US and other international pharmaceutical legislation
- Other relevant laws and guidelines
QP Module: Pharmaceutical Law & Administration 19/Oct/2015 More info and booking -
Medicinal Chemistry & Therapeutics
This module provides essential information upon which key technical decisions regarding the fitness for use of manufactured batches can be properly made.
These decisions may involve:
- Cross-contamination
- Patient risk
- Product quality
Please contact us for information about this module and when it is running.
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Formulation & Processing
Once a new chemical entity has proved its potential in clinical studies, the challenge begins to formulate the compound into an effective medicine and to manufacture that medicine reliably so that safety, quality and efficacy are assured.
This module addresses the two important activities of formulation and processing and provides key information on…
- How the physico-chemical attributes of the drug and the therapeutic indication
influence: route of administration and dosage form - Assuring bioavailability
- Methods of manufacture of the major dosage forms
Please contact us for information about this module and when it is running.
- How the physico-chemical attributes of the drug and the therapeutic indication
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Pharmaceutical Microbiology
Microbiological contamination of products and processes continues to be a major concern to the industry and its regulators. The potential impact of such contamination can be catastrophic. Put simply, microbial contamination can kill your patients and your business!
This course, for non-biologists and microbiologists, is designed to provide you with the knowledge, confidence and decision making risk assessment skills to prevent this happening.
QP Module: Pharmaceutical Microbiology 18/May/2015 More info and booking -
Active Pharmaceutical Ingredients
The quality of a medicine depends in no small part on the quality of its ingredients, and in particular the active. Thus, the Qualified Person and other key professionals in dosage form manufacture must have a thorough understanding of how the manufacture and control of the active and its supply chain may influence the fitness for use of the finished product.
This is recognised by the regulators, especially in Europe where the adoption of Directive 2004/27/EC has put the responsibility for assuring the quality of the active firmly on the shoulders of the dosage form manufacturer, with certain expectations specifically for the QP.
This course is designed to provide you with the knowledge and understanding to fulfil your responsibilities with competence and confidence.
QP Module: Active Pharmaceutical Ingredients 15/Jun/2015 More info and booking QP Module: Active Pharmaceutical Ingredients 12/Sep/2016 More info and booking -
Mathematics & Statistics
The introduction of the EU requirement for Product Quality Reviews together with ICH Q8, Q9 and Q10 mean that the Pharmaceutical Industry and the Regulatory Authorities are becoming increasingly aware of the benefits that statistical techniques can provide and the vital information that can be obtained by trend analysis. This module is designed for delegates who have little or no experience in the application of statistical techniques.
The provision of useful information is essential to the Qualified Person and other professionals in helping them to:
- Understand the reliability and accuracy of data and information arising from samples taken from a population
- Monitor and detect adverse trends before a process goes out of control
- Assess the capability and reliability of a process
- Understand the interaction of process parameters via experimental design
QP Module: Mathematics & Statistics 14/Sep/2015 More info and booking -
Analysis & Testing
A fundamental part of the Qualified Person’s release decision is the review and interpretation of analytical data. It is therefore essential that the Qualified Person understands the basis of the analytical techniques and their respective strengths and weaknesses.
This module seeks to provide a foundation of knowledge to enable the Qualified Person to judge analytical data, to be able to ask relevant questions to aid interpretation and to know when to call for additional data/advice.
QP Module: Analysis & Testing 16/Nov/2015 More info and booking -
Pharmaceutical Packaging
Despite advances in technology, quality problems with packaging still continue to occur. Print origination and packaging processes continue to be a major reason for product recall!
This module has been carefully designed to cover all important aspects of the packaging process, from selection of suitable components, pack design, packaging processes and their associated GMP challenges, through the supply chain to the patient.
The course includes visits to a wholesaler and a pharmacy, with input from printed packaging component suppliers.
The module aims to provide the necessary understanding of packaging materials and the packaging process to enable the Qualified Person to carry out his/her duties with knowledge and professionalism.
QP Module: Pharmaceutical Packaging 18/Jan/2016 More info and booking -
Quality Management Systems
We all know that the quality of your products depends on the quality of your people and the effectiveness of your Quality Management System (QMS). In fact, as Qualified Persons (QPs) and quality professionals, you can’t release product and stay in business unless your QMS is ‘in control’. This is easier said than done. Supply chains are more complex than ever before and you are being asked to do more with less, and faster! It is not surprising that failures in QMS are a key reason for severe regulatory action in Europe and the USA.
This course will provide you with answers to some really tough questions.
QP Module: Quality Management Systems 13/Apr/2015 More info and booking QP Module: Quality Management Systems 14/Mar/2016 More info and booking -
Practical Module
One of the greatest challenges facing the prospective QP is gaining a practical understanding of the equipment and procedures used to manufacture and test the broad range of dosage forms produced by the pharmaceutical industry. It is still true to say that the majority of candidates who fail at interview do so because they do not display a practical knowledge of the pharmaceutical manufacturing and testing procedures and their key vulnerabilities.
This module aims to assist the prospective QP by providing basic practical experience in these areas for the major dosage forms. This cannot take the place of practical experience in your company’s manufacturing areas and laboratories, but does provide ‘hands-on’ experience for a broad range of products and expert tuition from pharmaceutical specialists using the modern facilities of the University of Strathclyde’s School of Pharmacy which are used for research and teaching in Pharmacy and Biomedical Sciences.
This module is open to students from other QP training courses whose syllabus does not provide practical tuition, but as places will be strictly limited, early booking is strongly recommended.
QP Module: Practical (Formulation, Manufacturing, Analysis) 09/May/2016 More info and booking -
Investigational Medicinal Products
The adoption of Council Directive 2001/20/EC means that:
- All clinical trial materials must be made in accordance with the principles of GMP
- Manufacturing facilities must hold an appropriate authorisation and will be subject to inspection by the regulatory authorities
- All investigational medicinal products must be subject to certification by a Qualified Person prior to release into a trial
This course is designed to provide existing, trainee and transitional Qualified Persons with the foundation knowledge and understanding required to assess and certify investigational medicinal products and to appreciate the fundamental differences between IMPs and licensed products. It will also be of value for other technical staff working with clinical trial supplies.
QP Module: Investigational Medicinal Products 13/Jun/2016 More info and booking -
Role & Professional Duties of the QP
The principal objective of this course is to emphasise how the QP should conduct themselves in discharging their legal duties. Of paramount importance is the ability to focus on the broad issues of managing quality and to bring these issues together in a cohesive way when making decisions to certify medicinal products.
Throughout the course, therefore, delegates will have the opportunity to test their skills via interactive “release or reject” scenarios.
The role and duties of the QP are constantly being added to and it is essential that QPs keep up to date with these new expectations. This course covers these new challenges in detail to help you understand them and their impact.
The course will also include a simulation of a typical UK QP interview as conducted by the three professional bodies.
QP Module: The Role and Professional Duties of the Qualified Person 20/Jul/2015 More info and booking QP Module: The Role and Professional Duties of the Qualified Person 25/Jul/2016 More info and booking
Evening Sessions
‘Free’ QP Skills Sessions
NSF Health Sciences partners work with specialists in the area to ensure delegates receive the best training and support. Free optional evening sessions are scheduled on the majority of modules to help candidates develop the managerial skills to complement their technical knowledge.
Topics covered include …
- Learning Styles
- Presenting Skills
- Assertiveness
- Team Style
- Dealing with Conflict
- Influencing Skills
- Mind-Mapping
- Change Management
- Bio-Assays
- Interview Techniques
- Time Management
- Embracing Change
- Problem Solving/Creative Thinking
Course Entertainment
In addition to the optional ‘free’ management skills sessions scheduled for the majority of modules, we also arrange a course dinner for all delegates and tutors, usually on the Thursday evening, along with some entertainment.
What you've said
Here at NSF Health Sciences we pride ourselves in providing what we believe is the best QP training available in Europe. And to prove it this is some of the feedback we have received from some of our QP Core Delegates
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“David Begg Associates provide first class training services that will greatly assist any prospective candidate in their quest for eligibility to act as a Qualified Person. The structure of the course allows candidates to join and leave at any point in the series which provides flexibility in meeting your training needs against a busy work schedule. The course content revisits key themes on different modules to ensure a thorough understanding of how certain aspects interlink between the different modules. The style of teaching and learning that DBA promote, is interactive meaning that core messages are first delivered by traditional methods and then emphasised through team work sessions which greatly assists full understanding and comprehension.
DBA training always takes place in high quality venues with the people delivering the course content being recognised as industry experts. I would have no hesitation in recommending DBA as the leading training provider in respect of the QP study guide.”Shawn Murtough, Compliance Officer, Penn Pharma
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“I just wanted to drop everyone at DBA a short note to inform you of my recent QP viva success and thank everyone of you, for the part you played in helping me get there. Everything about the DBA set up helped me in one way or another. The one to one tuition with my assigned mentor provided an excellent opportunity to tap into the knowledge of all of his years of experience. The balance between ‘chalk and talk’ presentations and ‘hands on’ problem solving worked well for a variety of learning types and definitely helped me understand how to approach difficult working situations. Even the attention to detail from you, performing training on the softer skills of presenting, influencing and learning styles in conjunction with the technical aspects of the job. You covered everything. I’m proud to be part of the ‘DBA club’ and will keep on coming back to you for advice in the future. You are more than just training providers. You have the future of the industry at heart, the sanity of the QP in mind and provide a wonderful opportunity to make new friends.
Thanks again”
Stephen Clarke, Manager, Quality GMP, Aptuit Ltd
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“Why I chose DBA - We looked around and found two alternatives for QP training, one in the south of England and DBA where most of the training took place in the beautiful city of York - Being at a company based in Leeds it was a no brainer. York’s on our doorstep
Also:
• DBA modules give a broad and highly detailed coverage of each topic
• DBA use a large number of tutors with specialist experience and even have MHRA inspectors providing some training
• DBA use appropriate site/experience visits to supplement the training
• DBA have a challenging and enjoyable practical module as part of the training course so you can get hands-on experience of analysis, formulation and steriles
• DBA have a tutor system to assist/encourage core delegates with the training programme
• The number of people attending each DBA module indicates the training is popularHaving decided to go with DBA I found …
• Each module is fully documented in an ample training pack - augmented with additional documents, references and at times with additional text books. There is no need to sit and scribble and miss vital points
• These notes form the basis of my QPs reference library which is in regular use
• Each module consists of an engaging mixture of lectures, discussions and small to large group activities (Buzz groups - and yes the air really buzzed at times)
• The modules are not just attended by trainee QPs
• The variety of people attending each module leads to lively discussion and debate both in the lecture room and outside
• The DBA lecturers and tutors do everything to assist you in their understanding of the topic
• They will go over issues with the class, a group or individually until the penny drops
• The course isn’t just about being taught it’s an opportunity for self development
• All kinds of opportunities are taken by DBA to develop those attending - from getting people to present to the group or class to arranging separate additional training sessions on “soft skills”
• It was clear that the DBA staff really listen to the people they train
• DBA go the extra mile - the additional help and assistance I had from them in preparation for my QP viva was invaluableBecause of DBA I now have a list of over thirty contacts throughout the pharmaceutical industry who I can call on and who call on me for help with work related issues
So DBA was the right choice for QP training and as a QP
At the start of my training I was told by one of the DBA tutors that this course would change me - I didn’t believe it then - but I believe it now”
Richard D Brown, Validation Co-ordinator, Qualified Person, Rosemont Pharmaceuticals Ltd
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““David Begg associates provided me with the most comprehensive QP training I could have hoped for. I can understand why the training is held in such high regards as the tutors’ delivery, experience and importantly their focus on personal development is exceptional.
The environment in which the course is run allowed me to develop a strong and effective network with other quality professionals which you can’t put a price on!
David Begg are an example of ‘best in class’ and I believe their approach to training produces quality professionals that can draw on experience from all areas of the industry.”
Ian Birch, Roche Pharma AG
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“Our Formulation and Processing module took delegates through the manufacture of sterile products, metered dose inhalers and liquids, creams and ointments. The theory, the practice, the risks, challenges and pitfalls. As with all our modules, numerous case studies and real life QP scenarios challenged their problem solving and risk based decision making skills. Those with stamina also attended our free QP Skills evening sessions on ‘Accelerated Learning’ and ‘Change Leadership’.”
Martin Lush, President, NSF Health Sciences Pharma Biotech
Role of Honour
- Nigel Adams
- Gareth Adlam
- Stuart Allen
- Paul Anderson
- Richard Angwin
- Kate Barker
- Lynda Baker
- Suzanne Ball
- Justin Barry
- Cathy Bateman
- Daniel Bell
- David Belshaw
- Christine Bennett
- Neil Bennett
- Dale Billingsley
- Sonia Bradford
- Lynn Bryan
- Philip Butson
- Samantha Clack
- Robert Clarke
- Neil Connor
- Peter Cormack
- Roy Cowell
- Bruce Cuthbertson
- Kris Davé
- Faith Daykin
- Martin Dearden
- Peter Deegan
- Karam Dhaliwal
- Robert Dilks
- Elaine Dymond
- David Earl
- Sam Elcomb
- Grant Elliott
- Clare Embley
- Elizabeth Evans
- Marcus Evans
- Karl Fry
- Richard Funnell
- Mayuur Gohill
- Amanda Hall
- Johan Havinga
- Paul Henly
- Nick Hill
- Nigel Holcombe
- Judith Hoodless
- Mark Hughes
- Sandra Illsley
- Ronald Imhoff
- Mike Irving
- Ian Jackson
- Sukhbinder Jaiswal
- Hazel James
- Phil Jenkinson
- John Johnson
- Adam Jones
- Jantine Jonkman
- Julian Kay
- Tony Kern
- Mark Kind
- Boudy König
- Sheila Lachut
- Bob Lambert
- Trevor Lees
- Fraser Leslie
- Brian Lewis
- Debbie Lloyd
- Alison Lockett
- Tony Loeffen
- Veronika Lothian
- Martin Lush
- Karen Lynch
- Fiona MacIntyre
- Tony Mayhall
- Graeme McBurney
- Robert McConnell
- Thomas McHale
- Fiona McLaren
- Wallace McRobert
- Kim Morwood
- Stephen Moss
- Derek Murphy
- Shirley Mutch
- Anneke Nederbragt
- Deborah Nugent
- Russell Nugent
- Paul O’Connor
- Brendan O’Dorman
- Tony Osbourne
- David Palmer
- Philip Parry
- Zen Pawlack
- Andrew Pentelow
- Anna Pickering
- Ian Pounder
- Martine Powell
- Nick Precious
- David Preston
- David Price
- Neil Raw
- Annie Rietveld
- Mike Roberts
- David Robinson
- Richard Rogers
- David Ross
- Michael Rowe
- Monika Sauter
- John Seager
- Jane Shaw
- Stephen Simpson
- Cate Sims
- Richard Smalley
- Robert Smith
- Scott Smith
- Andrew Spence
- Martin Spencer
- Peter Stancliffe
- Wendy Steele
- Paul Stockbridge
- Paul Thomas
- Emma Thomson
- Bill Thorne
- Mandy Turgoose
- Pamela Turner
- Lena Vägberg
- Piet Van Rens
- Maria Vincent
- Indira Walker
- Neil Wayman
- Gordon Whittle
- Richard Wilford
- Richard Wilkins
- Sam Williamson
- Kevin Wilson
- Christopher Woodage
- Paul Wright
- Jane Williams
- Gareth Naylor
- Mark Girdwood
- David Ling
- Alan Mayo
- Mukesh Patel
- Rachel Mizzi
- Nick Branch
- Mark Sephton
- Leonor Arrebola
- Hemal Patel
- Emily Rumsey
- Jennifer Watson
- Catherine Kay
- James Muller
- Daniel Pilkington
- Peter Gannon
- Joanne Lewis
- Matthew Jaynes
- Chris Miller
- Gillian Morris
- Colin Newbould
- John O’Neill
- Graeme Perkins
- Angela Hoskins
- Jenni Newcombe
- Vicky Baulch
- Jane Colman
- Mark Dignum
- Bruce Vernon
- Trevor Clarke
- Derrick Jones
- Simon Tanner
- Tim Dickinson
- Treena Edwards
- Meriam Lindsay
- Mark Hinton
- Helen Brannan
- Ruth Buchanan
- Tony Pinney
- Dawn Harrison
- Kate Krachai (nee Mirfin)
- Breda Quinn
- Ronnie O’Connell
- Stephen Davenport
- Dru Homer
- Neil Smith
- Ed Teece
- Claire Pierce
- Barbara O’Dwyer
- Cecile Begat
- Jordan Costello
- Trevor Watson
- Robert Clayton
- John Tognarelli
- Philip Millward
- Justin Ahern
- Colin Chambers
- Kathryn Rooney
- Amanda Race
- Rachel Evans
- Nigel Morton
- Richard Brown
- Shawn Murtough
- Ian Birch
- Claire Montgomery
- Giby George
- Jonathan Dormer
- David Jamieson
- Stefan Verstegen
- Peter Kendrick
- Chris Forrest
- James Culyer
- John Horry
- Chris Hinds
- Maria Adesida
- Jack Beattie
- Donna McKenna (nee Stewart)
- Richard Brown
- Stephen Clarke
- Philip Davies
- Nigel Chesterton
- Jonathan Bradshaw
- Sarah Gardiner
- Shaun Barford
- David Thomson
- Azhar Salahudeen
- Claire Trumper
- Jason Morris
- Phil Cryan
- Eurwyn Roberts
- Stephan Croft
- Leen van de Water
- Jacqueline Barry
- David Franks
- Hazel Pitt
- Linden Stead
- Adam McLennan
- Laura Matthys
- Jasbir Rattu
List as per 6 March 2026
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FAQs
Here are the answers to the most common question we get regarding the QP Training Programme. If you do not find the answer to your specific question, please, do not hesitate to contact us.
- Q. 1. Prospective QPs: Do I need to attend all the modules?
- Q. 2. Prospective QPs: How can I decide which modules to attend?
- Q. 3. Prospective QPs: How long does the course take?
- Q. 4. Prospective QPs: How do I enrol for the Postgraduate Certificate?
- Q. 5. Prospective QPs: How do I enrol for the Postgraduate Diploma/MSc?
- Q. 6. Prospective QPs: I’ve heard about the tutor system what is it?
- Q. 7. Prospective QPs: Do all modules cost the same?
- Q. 8. Prospective QPs: Once the series is finished do I still have use of DBA’s advice and consultancy?
- Q. 9. Prospective QPs: What is the success rate of DBA delegates at viva?
- Q. 10. Sponsors: If a delegate is on a QP course, but not a ‘core’, can they do exam?
- Q. 11. Sponsors: Can the Sponsor accompany the delegate to the ‘revision interview’ at DBA?
- Q. 12. Sponsors: What is the pass rate at each of the Joint Professional Bodies?
- Q. 13. Sponsors: How many assessments are done?
- Q. 14. Sponsors: Has the viva changed over the years?
- Q. 15. Sponsors: What is required of a Sponsor?
- Q. 16. Sponsors: Who is the best person to be a Sponsor?
- Q. 17. Sponsors: Should the Sponsor be a ‘permanent’ QP?
- Q. 18. Sponsors: Have you failed anyone who has approved because they were shy/quiet?
- Q. 19. Sponsors: Can you put too much information into the QP application form?
- Q. 20. Sponsors: Has the Sponsor been challenged if form is misleading or lacking in information?
- Q. 21. Sponsors: How do you decide on questions for candidates at viva?
- Q. 22. Sponsors: Do the Assessors expect quick responses to questions?
- Q. 23. Sponsors: If a candidate has not been on a training course but has perhaps read another candidate’s notes who has, could that be put on QP application form?
- Q. 24. Sponsors: Is anyone else present during the viva?
- Q. 25. Sponsors: What would the MHRA be observing for?
- Q. 26. Sponsors: Are all MHRA Inspectors QPs?
- Q. 27. Sponsors: What happens if a candidate is failed - is there an appeal process?
- Q. 28. Sponsors: Isn’t it up to DBA to make sure Sponsors are fully aware of what is required of them?
- Q. 29. Sponsors: If a candidate fails first time are Assessors aware of those areas which caused the failure and do they focus on those on the second viva?
- Q. 30. Sponsors: Are there many situations where Assessors disagree on outcome?
- Q. 31. Sponsors: How do you ensure consistency of Assessors?
- Q. 32. Sponsors: Is there always a member from the same Joint Professional Body as the candidate?
- Q. 33. Sponsors: Has anyone passed the viva without having used a training provider?
- Q. 34. Sponsors: Do candidates approach Sponsor if interested in becoming a QP or does the Sponsor identify the candidate(s)?
- Q. 35. Sponsors: If you have a suitable candidate in Production would you transfer them to the Quality Department?
- Q. 36. Sponsors: Can a ‘transitional’ IMP QP work for another company outside the UK?
- Q. 37. Sponsors: What happens to the Sponsor/trainee QP relationship when the trainee moves company?
- Q. 38. Sponsors: Is it worth accessing scenario questions put to good, successful candidates?
- Q. 39. Sponsors: If candidate(s) offered a cancellation date which is a lot earlier than original date, would they be ready for viva?
- Q. 40. Sponsors: Do the Assessors expect candidates to provide answers straightaway at the viva or do they allow some thinking time?
- Q. 41. Sponsors: At viva how much time is spent talking about your own dosage form and how much on other dosage forms?
- Q. 42. Sponsors: What is expected of candidates going forward with mainly API experience and how do they get experience on site with an ML?
- Q. 43. Sponsors: What experience are Assessors looking for within the required 2 years practical experience?
- Q. 44. Sponsors: What is the selection process for trainee QPs?
- Q. 45. Sponsors: Is only one sponsor required?
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- Q. 4. Prospective QPs: How do I enrol for the Postgraduate Certificate?
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A.
The University of Strathclyde coordinates their qualification directly with the delegate but do let your tutor know and/or Stella who will inform the University in the first instance. The requirements for the Certificate are …
attend three foundation modules and three of choice, perform satisfactorily in the module assessments, sit the Certificate exam at the University
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- Q. 5. Prospective QPs: How do I enrol for the Postgraduate Diploma/MSc?
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A.
The University of Strathclyde coordinates their qualification directly with the delegate. Typically the requirements for the Diploma are …
attend all modules, pass both papers of the module exams, sit the Diploma exam at the University
The MSc requires the above plus a workplace thesis/project, approved by the Course Director at the University.
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- Q. 6. Prospective QPs: I’ve heard about the tutor system what is it?
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A.
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
- core delegates are also offered a free revision interview 6-8 weeks before their viva to assess the delegates readiness for the viva
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- Q. 8. Prospective QPs: Once the series is finished do I still have use of DBA’s advice and consultancy?
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A.
Yes. Past delegates on DBA courses are always welcome to contact DBA 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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- Q. 10. Sponsors: If a delegate is on a QP course, but not a ‘core’, can they do exam?
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A.
Yes, an exam can be sent to a ’nominated’ person at place of work - exam should be taken under exam conditions with nominated person invigilating. Please Note: These exam results would not count towards any of the postgraduate qualifications if sat at the workplace.
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- Q. 13. Sponsors: How many assessments are done?
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A.
Around 15 Assessment Days planned per year but is ultimately varied to accommodate the number of candidates requiring vivas. Three assessments per day typically, resulting in 2-3 passes, rare to get 2 or 3 failures (but not unknown). Each candidate is taken purely on their own merits.
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- Q. 14. Sponsors: Has the viva changed over the years?
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A.
There are more scenario-based questions asked of the candidates now so the Assessors can get an idea of how well they would deal with such situations and prevents candidates from just regurgitating information and facts. Although the style has changed it has not altered the pass rate.
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- Q. 15. Sponsors: What is required of a Sponsor?
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A.
The Sponsor should know the candidate well and be aware of their roles and responsibilities. It is preferable that the Sponsor is a QP but not essential. The Sponsor should be a member of one of the relevant professional bodies. If this is not possible, advice should be sought from the QP Officers at IOB, RSC or RPSGB.
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- Q. 16. Sponsors: Who is the best person to be a Sponsor?
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A.
It is vital the Sponsor has the time and commitment and is completely honest. The Sponsor should be intimately involved with the QP’s training and development. It is up to the Sponsor to decide if the candidate is cut-out to be a QP. If you do not have the time and commitment then you are not the right person to sponsor a candidate through the lengthy and detailed process required.
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- Q. 21. Sponsors: How do you decide on questions for candidates at viva?
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A.
Each candidate’s QP application form is reviewed by the Assessment Panel and questions tailor-made. The same questions are not used for each candidate. The Assessment Panel would ask detailed questions on the core elements of the Study Guide; interspersed with scenario questions that encompass several modules. It is expected that candidates will be able to answer questions on the core elements with confidence and depth. Scenarios chosen will be relevant to the candidate’s preferred dosage form, experience or training. Questions seek depth of suitability in core areas and across the study guide.
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- Q. 24. Sponsors: Is anyone else present during the viva?
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A.
Occasionally there may be a trainee assessor sitting in on a viva and occasionally observers from the MHRA may be present. In either event the candidate is made fully aware of who is in the room and introduces them. The Sponsor is not allowed in the room with a candidate but can wait outside.
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- Q. 27. Sponsors: What happens if a candidate is failed - is there an appeal process?
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A.
Yes there is. Advice on appeals can be sought from the QP Officers at IOB, RPSGB or RSC. When a candidate fails to convince the assessors of his/her eligibility, the chair of the Assessment Panel delivers the decision directly after the viva. The Panel will offer guidance on where the candidate fell short of expectations and may offer non-binding advice on what could be done to bridge any gaps before re-applying. This is followed up in writing by the QP officer directly to the candidate. Candidates can sometimes misunderstand why they were unsuccessful or not recognise the gaps in their knowledge or experience. QP officers can help with this. Candidates are very welcome to contact any of the QP Officers at any time if they require further information or help in identifying gaps. Appeals are rare and exceptional events though there is a procedure to deal with any issue of this kind.
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- Q. 28. Sponsors: Isn’t it up to DBA to make sure Sponsors are fully aware of what is required of them?
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A.
Yes, to a certain extent. It is a difficult decision for a Sponsor to make on their own as to whether a candidate is suitable and DBA are happy to provide input on how candidates are progressing with the training. DBA arrange meetings for tutors and tutees at each of the modules and help and advice is given to those who want it; some candidates do not turn up for these appointments. At the revision interview advice is given as to whether the candidate is ready to progress to viva.
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- Q. 29. Sponsors: If a candidate fails first time are Assessors aware of those areas which caused the failure and do they focus on those on the second viva?
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A.
Yes the Assessors would cover those areas of weaknesses from first viva plus new interview material. All Assessors are aware of the history of candidate. The pass rate is no different for successive attempts.
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- Q. 35. Sponsors: If you have a suitable candidate in Production would you transfer them to the Quality Department?
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A.
It would be preferable to have a candidate already working in Quality but there is potential for such a candidate. The best candidates tend to have a broad career in different pharmaceutical disciplines or a broad, comprehensive training and development plan or preferably both.
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- Q. 37. Sponsors: What happens to the Sponsor/trainee QP relationship when the trainee moves company?
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A.
Depends on what stage they are at and if the new company can provide a suitable Sponsor. If they are nearing the end of their QP training then it would make more sense to keep going with the previous Sponsor but, if necessary, more than one Sponsor can fill in the Sponsors Report.
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- Q. 41. Sponsors: At viva how much time is spent talking about your own dosage form and how much on other dosage forms?
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A.
Majority of questions are on your own dosage form but assessors would expect candidates to be able to answer scenario-based questions on other dosage forms. An example would be if you changed employer and the dosage form is different then the assessors would need to know how you would update your CPD and what you would do in the first 3 months etc).
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- Q. 42. Sponsors: What is expected of candidates going forward with mainly API experience and how do they get experience on site with an ML?
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A.
It is more common now to find candidates going forward with API experience. The candidate would be asked what knowledge they have of downstream processes of that API. Candidates must have two years experience in a role based at a site with a ML. This rules out most but not all API sites. The exceptions are where MHRA have advised the site that they need a ML as …
- The API is formulated with other excipients ready for e.g. thawing and fill/finishing as a drug product
- The API is deemed a drug product in that no further formulation is needed
There are a few sites in the UK that come to mind but these tend to be exceptional.
If a candidate is doing the course whilst based at a site that does not have a ML, the only advice is to seek a temporary secondment or permanent role elsewhere. Without 2 years experience at a site with a ML the candidate cannot meet the needs of the Study Guide. In case of any exceptional circumstances the candidate should seek advice from the QP Officer at the professional body that they are aligned to and of course this should be a serious consideration before embarking on a period of QP study.
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- Q. 43. Sponsors: What experience are Assessors looking for within the required 2 years practical experience?
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A.
Candidates should have experience in QC, Packaging/Production, Supervisory roles, QA - part of manufacturing/testing on a site with an ML. Plus interaction with QP and supply chain coordination etc.
Useful Links
- Guidance Notes to Assist the QP
- Royal Society of Chemistry
- The Society of Biology
- Royal Pharmaceutical Society of Great Britain
- New Route to Membership of the CQI
- QP Series 13 Brochure Oct 14 - Sept 16
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