A Call for Croatian Translators

This week saw the EC advertise for Croatian translators via Twitter.  Now you may be thinking how this relates to a QP training blog?

On the 1st of July this year Croatia will become the 28th member of the European Union.    As a QP you are expected to have a 'comprehensive knowledge of all EU and national legislation relating to the manufacture, storage & supply of medicines...' as defined by the QP study guide.  In order to have this knowledge you first need to know which countries are legally bound to this legislation and which countries are likely to join in the near future.

The EC Europa website gives a useful overview of the status of the EU member states and importantly those countries that are in the process of applying for membership.  In order to get to the first step in the process the country has to meet strict conditions for membership including incorporation of the 35 policy chapters of the EU, including chapter 28 (consumer & health protection) that covers EU legislation on medicines.

Potential countries are grouped into 3 categories depending on their current status.  The first category is for Potential Candidates and are invited to formally begin application proceedings only when they are ready.  As countries progress through their application they then become a Candidate Country and finally an Acceding Country once EU membership terms have been agreed.

Current Status of EU enlargement:

Category	Country
Acceding Country	Croatia (Entry 1st July 2013)
Candidate Countries	Macedonia, Iceland, Montenegro, Serbia, Turkey
Potential Candidates	Albania, Bosnia, Kosovo

Montenegro and Iceland are the 2 candidate countries where negotiations have been ongoing for a number of years.  These countries are the most likely to become acceding countries over the next few years. 

Relevance to the QP viva?

Having knowledge on the countries that are nearing EU membership (particularly the acceding countries) will help in your preparation for the common 'round the world' supply chain questions and scenarios.  These typically involve importation of APIs, intermediates or final products into the EU via a number of 3rd countries. 

Taking Croatia as an example, from 1st July 2013 it goes from a 3rd country to a Member State.  Therefore if you viva is coming up soon there is a high chance that the assessors will include Croatia in their supply chain scenario.  If you fail to recognise that Croatia is a 3rd country before 1st July 2013 then it is highly likely that your answers regarding importation will be incorrect and will obviously not go down well with the assessors. Having an awareness of upcoming additions to the EU shows the assessors that you understand the structure of the EU & have an appreciation of how the continuously evolving landscape within Europe affects your role as a QP.

The table below highlights some factors relevant to QPs regarding the inclusion of Croatia into the EU:

	Croatia (pre 1st July)	Croatia (post 1st July)
Legal Status	3rd Country	Member State
Finished product import Croatia into UK	Testing on import required	No testing on import required
API import Croatia into UK	Written confirmation would have been required	No restriction
QC Testing location	Importation Testing not permitted	Importation testing allowed
Retention Sample	Cannot be stored here	Can be stored here
IMP comparator sourcing	Unlikely to be sourced (equivalent EU GMP to be determined)	Likely to be sourced (EU GMP incorporated into local law)

  

Summary

As I've mentioned previously it's important to maintain up-to-date regarding the relevant legislative & GMP updates in preparation for your viva and throughout your QP career.  I would also recommend to include the structure of the EU (including EEA, EFTA etc) as well as upcoming changes as part of your update strategy leading up to your viva.  Including this RSS feed into your updates folder is highly recommended.

Friday's Round Up

USA on API white list

From next week the USA will be on the EU's white list regarding written confirmation of API imports from 3rd countries.  The USA now joins Australia, Japan & Switzerland on the white list.

Class 1 recall – Ambisome Injection

Potential lack of sterility assurance was the typically vague term used by the DMRC in describing the reason behind this recall.  Unfortunately no further information is provided  but it is worth considering the possible causes such as primary container defects, media fill results, PV complaints….  Ambisome is a critical product so a recall indicates the severity of the problem.

Aspirin tablet recall (FDA)

An example of segregation/line clearance error during packaging.  The aspirin bottle actually contained paracetamol tablets.  This should immediately draw your attention to the potential extent of the problem – ie where have the aspirin tablets gone? (in the paracetamol labelled container perhaps?  which would have the greatest risk to patients? - this is where your medicinal chemistry should help in your assessment!)

WHO guideline on QRM

These guidelines build on Q9 and provides more detailed information regarding the implementation of QRM.

EMA Q&A – Annex 1 bioburden

EMA clarifies the point at which bioburden testing should be performed (immediately prior to filtration) and bioburden limit (10cfu/100ml).  This is part of the ongoing GMP Q&A section of the EMA website that gets updated periodically but without much fanfare.

EMA guidance update on ASMF submission

This provides some details on the letter of access that API manufacturer’s use to give the regulatory authority permission to review all the commercially sensitive data regarding the API manufacturing process.   The withdrawal of access letter has been given more guidance for when API manufacturer changes or the ASMF is replaced by the CEP.

Single use Technology for biotechnology manufacturing

A useful insight to the disposable systems in use for biotechnology manufacture.  These remove the need for cleaning validation, reduce contamination and saves significant time where cleaning of multi use biotech equipment can significantly reduce the available manufacturing capacity.

Pharmafile provides a nice overview of MHRA action regarding API importation (as mentioned in last week’s post)

Happy reading!

Friday's Round Up - June 14th

This is the first of my weekly round up posts.  The aim of these is to provide an overview of any news articles, stories or anecdotes I come across during the week that may be relevant to trainee QPs. 

WHO Water Guidelines
These were published last October but only found their way to my updates folder this week.  A good overview of water systems for those with limited first-hand experience in them

Ventolin Syrup Recall (MHRA)
A class 2 recall from Glaxo Wellcome due to the potential for glass particle contamination within the syrup.  As always the recalls provide a great scenario question to test out your thought process in dealing with the initial complaint/defect. 

Vecuronium Bromide Injection Recall (FDA)
Sagent Pharmaceuticals are recalling a number of batches due to an elevated impurity result from routine testing (assuming ongoing stability testing).  Again, start thinking of the questions you would need in order to provide more information if presented with this during the viva.  For example - confirm the impurity result & with OOS investigation would be one of my first things to clarify......followed closely by identifying the impurity....

Warfarin 2mg recall (FDA)
Zydus Pharmaceuticals is recalling one batch due to oversized tablets.  This product is presented in 1000 tablet bottle and is a good example of a dose critical product where both overdose and underdose can have significant clinical consequences.    

Cilest Recall
J&J adding to the baby boom!  Anyone fancy performing the reconciliation on a recall of 32 million units?!

Ph Eur monograph update proposal for Glass containers for Pharmaceutical Use
From Tim Sandle's excellent site details a proposed update to monograph 3.2.1. regarding control of production of glass containers as well as QC testing for hydrolytic resistance. 

Updated EMA Q&A on APIs
A number of questions within this document were updated in May.  There are some that are related to the QP such as the regulatory expectation of API audit contents, qualification of API auditors (questions 8, 9 & 10).  Useful information for the FMD and round-the-world related viva questions.  (Remember - GMP Part II doesn't directly apply to IMPs)

MHRA update on API imports & written confirmation
A post that will probably lead to more work for the QP.  This outlines the MHRA's plan for the July deadline for written confirmation of APIs from 3rd countries following FMD requirements. 
The interesting section is: 
'Where UK Manufacturing Authorisation Holders ("MIA Holder") have determined that their third country AS sources are at risk and have not been contacted by MHRA they should provide evidence in the submission / declaration...'

I think it is safe to assume that 'MIA holder' will be substituted with 'QP'..... !

EMA Q&A document on Israel-EU MRA
Interesting document that covers the product types included and not included.  Interestingly GMP certificates issued prior to the MRA implementation date are considered valid

Japan added to EMA's white list for API import
The list of 3rd countries now on the white list is: Australia, Switzerland & Japan.  API imports from these countries will not require written confirmation for each batch imported into EU.   USA, Israel & Brazil are currently under evaluation.

Happy reading!

Study Toolbox Part 5: Visits

This post will provide a guide to getting the most out of your visits and hosting reciprocal visits of fellow QP trainees.  Visits will form a significant part of your QP training.  For most of us our working environment will not cover all the dosage forms and relevant aspects within the study guide.  Even those trainees working for large multinational companies there will likely be areas of the study guide that they wont be able to cover within their respective company.  This is especially important for those trainees within specialist areas such as PET radiopharmaceuticals, ATMP & medicinal gases.

Tips for arranging visits:

1.  Gap analysis

A gap analysis of your current CV or draft application form against the study guide will identify areas that you are not familiar with.  Listing these will form the basis of the ideal visits that you'd like to arrange to plug these gaps.  Your sponsor should be heavily involved in this process to ensure that all areas are considered.

Coming from a NHS background I identified a number of areas I'd want to visit.  These included, water systems, high speed packaging lines, API manufacturer (biological & chemical), high speed sterile filling lines as well as RA & PV departments.

2.  Networking

Once you have identified the main areas that you'd like to cover you'll need a list of appropriate contacts of people who may be able to arrange a visit.  This is where your sponsor should be able to help.  They should have a great network of contacts that you can utilise. By now you may now have built up your own network from training courses, conferences, symposiums etc, so now is the time to dig out those business cards and start emailing.

3.  Arranging a visit

One of the most important aspects of visits is knowing what you want to get out of them before you go.  Your aims should be discussed with your sponsor and your host in order to determine how long you will need to meet these.  Once you set a date for the visit begin working on an itinerary with your host.  Sometimes your host will provide an itinerary but you will need to ensure everything that you want to cover is included - if it isn't then amend the itinerary.  If necessary be specific and focus on one main topic for your visit especially if your time on site is limited.  During one visit I focused solely on the facility's water system and nothing else as I only had a half day on site.

It is always worth asking for a scenario session with the host which covers typical examples (real life if possible) that occur within their processes. 

4.  Preparing for the visit

Leading up to your visit it is important to spend some time preparing for the things you'll likely be witnessing.  try to get as much background knowledge on the subject area before you go.  Your sponsor should be able to provide you with a good overview of the subject but there are some good alternative sources available to you. Before heading to visit a high speed packaging line I searched you tube for the packaging line manufacturer (Ulhmann) and found a number of useful videos which gave me an idea of what to expect.

5.  During the Visit

Don't turn up empty handed - always bring some biscuits, sweets etc for the host and their team.  The other important thing to bring with you is a memory stick/usb drive.  Most of the trainee QPs will have numerous electronic resources which they may be willing to share.  It helps if you bring some of your own to trade!

Its important to ask as many questions as possible especially if there is a certain process or piece of equipment that is of interest to you.  I found it useful to put your auditor hat on during visits as this will help you to identify areas of risk and can lead to discussions over critical control parameters and in-process tests.  With my visit to the high speed packaging line it was useful to relate that process to the manual packaging process I was used to.  Ultimately the same controls are in place - the only significant difference was the volume and automation used in high speed lines. 

'If you don't ask, you don't get'.  If there is something you'd like to see, whether that is a SOP, deviation report etc then ask!  I was lucky enough on one visit to be able to view a complete marketing authorisation.  As my main experience has been with IMPs I had never seen a MA before and hence this was an obvious gap in my knowledge!  This was asked for in advance by me and meant that this was scheduled into the itinerary.  As a result I had the privilege to be talked through the MA contents by the company's PVQP.

6.  Visit end

Ensure you get all the contact details from both the trainee QPs and qualified QPs on site.  This will help build your network and if the trainee QP is a similar way through their training then it could be an opportunity to arrange regular telephone sessions.  Always  offer a reciprocal visit for their trainees to visit your own site. 
Once back at base you should update your application form with what you have gained from the visit.

7.  The reciprocal Visit

Arrange a reciprocal visit follows the same steps outlined above.  Even though you may think you wont have much to offer someone from 'big pharma' remember that those trainee may have only ever experienced high volume pharmaceutical manufacturing.  I have hosted a few visits of commercial pharma trainees and I think they gained something by reviewing small scale IMP manufacture and specialist equipment such as laminar cabinets & isolators. 

Hosting visits is a really good way of validating your own knowledge in your systems & processes.  It is almost like being audited especially if the visiting trainee QP is bombarding you with questions!  Make the most of this as one of these questions may crop up during your viva.  Again, include some scenario questions, real-life deviations and how they were dealt with during the visit.  It is a good opportunity to see how someone other than your sponsor tackles specific problems. 

Summary

Visits are an important part of your QP training.  You should aim to make the most of your time on site with arranging itineraries before hand and identifying the main objectives of your visit.  Witnessing first hand enables you to visualise processes, equipment and their associated noise, smell and scale - far better than any book or lecture could. 

I have been very fortunate to have been on a number of visits to commercial pharmaceutical companies.  Personally I think coming from the NHS helps for once as we are not a commcercial competitor and the NHS for many companies is a large customer and therefore are often willing to give something back.  I have to thank the following companies for hosting me (and feeding me!); Teva, Rosemont, Eisai, Guy's Hospital, Amdipharm/Mercury Pharma & Wockhardt. 

If anyone would like to visit my facility please feel free to contact me via this blog or my Linked In profile.


Study Toolbox Part 1:  The Onion
Study Toolbox Part 2:  Introduction to Mindmaps 
Study Toolbox Part 3:  Keeping up to date 
Study Toolbox Part 4:  Training Courses

The Rise of Orphan Drugs

Approvals for Orphan drugs have been on the increase within both the USA and EU ever since legislation was introduced in an attempt to stimulate research into rare diseases.  The 1983 Orphan Drug Act and EU Regulation 141/2000 provided a new product class to which pharmaceutical companies can apply for marketing authorisations.  Both the EMA and FDA has seen a sustained increase in applications.  Approximately 30% of all applications for new molecular entities within the USA are for Orphan drugs and the EMA has seen a 40% increase over the past few years.

What is an Orphan Drug?

For a drug to be classified as an orphan drug the disease it is being used to treat must be designated an orphan disease.  Within the EU an orphan disease is one which affects less than 1 in 2000 patients per year and this disease must be registered with the EMA in order to gain orphan status.  This application (or sponsorship) is submitted by a corporate body, an individual researcher or a combination of both.  The sponsorship details both the orphan disease and a proposed treatment and once granted by the committee of orphan medicinal products (COMP) the sponsorship lasts for 10 years.  Within that 10 year period is it normally assumed that an application for a marketing authorisation will be submitted.  Interestingly only the holder of the orphan designation (sponsorship) can be named as the MA holder on the MAA for the treatment specified within the orphan designation.  An example of an orphan designation can be found here.

There are also a number of incentives available for pharmaceutical companies to invest in the development of orphan drugs.  These include tax relief, reduced MA application fees and most importantly product exclusivity for 10 years.  Many of these drugs, such as enzyme replacement therapies are designed to be a chronic treatment thereby requiring the patient to be treated for life.  This will obviously help companies offset the reduced size of the target population.  

With England the frequently quoted limit for new treatments to obtain NICE approval was typically £30k per patient per year.  With Orphan drugs there is no such limit as QALYs and the other pharmacoeconomic tools are harder to relate to rare diseases.  Cerezyme is a good example of this.  Within England the cost per patient per year is ~£140k.  In the States orphan treatments are now approaching $1m per patient per year for gene therapy drug Glybera.

Prior to the relevant orphan drug legislation there was little incentives for pharmaceutical companies to invest into treatments for rare diseases.  The traditional search for the next ‘blockbuster’ drug helped to drive the pharmaceutical industry into hunting for larger and larger markets such as cardiology and infectious diseases.  The shift away from blockbuster treatments to more personalised therapies has enabled clinical trials to be performed more efficiently by reducing subject numbers and stratifying trial subjects to known responders.  Clinical trials for orphan drugs may include as few as 10-20 patients and this will often form part of the marketing authorisation application. 

An MA to match

As the number of clinical trial subject can be very low the EMA can issue a conditional or exceptional circumstance MA for orphan drugs.  A conditional MA is issued on the basis that a full dossier will be submitted in the future covering long term safety & efficacy data.  Once submitted and approved the conditional MA then reverts to the traditional MA model.  Exceptional circumstance Mas are issued when a full dossier is unlikely to be issued in the future due to the small patient numbers involved.  The MA therefore becomes conditional on the MA holder performing long term safety studies and an annual assessment by the COMP.  The legal basis for exceptional circumstance MA is EU regulation 726/2004 and the EMA website provides a good overview.  The exceptional circumstance MA can therefore allow pharmaceutical companies to get their novel product to market sooner and without the costs associated with large phase 2 and 3 clinical trials.  It must be noted that the three pillars of marketing authorisations (safety, quality & efficacy) still apply to both conditional and exceptional circumstance MAs.   

Summary

The rise in marketing applications for orphan drugs can be attributed to a number of factors such as legislative developments, business incentives and the advancement of new technologies within the pharmaceutical industry.  From a trainee QP’s perspective this post does not offer a great deal of information to help with your viva.  However, being aware of how the pharmaceutical industry is changing is important to show an awareness of the bigger picture.  

The exceptional circumstance and conditional marketing authorisations would provide an additional layer to your law and admin knowledge. 

The Application Form

One of the most important pieces of the QP training jigsaw is the QP application form.  This and the Sponsor's form provide the professional body with documented evidence of the candidate's experience and is the first part of the assessment process.  The aim of the application form is to show the assessors that you have covered all the relevant knowledge & experience you need to act as a QP.  The assessors will compare your application form to the study guide to ensure all the requirements have been met.


The QP application form is analogous to a job application.  The application form is used to show you have the required skills and experience for the job and is primarily used to get you an interview.  The QP application should be treated in the same way - it is your ticket to being called for the viva.  Therefore it should be thoroughly checked for omissions and errors before submitting.  Your sponsor will play an important role here as they will need to countersign your application form.   Guidance for completing the application form for both applicants & sponsors can be found here and is definitely worth a read before making a start on your form. 

Tips for completing your QP application form 

     1.  Start early

Ideally you should start competing your application form as soon as possible.  Large sections of the application form cover personal details & employment history.  Most of these data can be lifted straight from your CV.  Even something as simple as this can take a lot of time so be prepared and plan your time effectively.  You can then build your application form over time as you gain experience from work, visits or training courses.

My sponsor left his application form till the end of his training thinking it would not take long to complete.  In the end it took him over 2 months to finish the application form!  At this stage of your training you want to be spending all your effort on revising not completing your application form     

     2.  GAP analysis

When populating your application form have the latest version of the study guide open.  Perform a gap analysis of your current application form content verses the content required by the study guide.  Your sponsor should be willing and able to do this for you.  Once you know the areas that require further work you can tailor your training program to meet these objectives.
 

After my initial gap analysis I typed out all the missing sections in red.  Once each section was completed I simply changed the font to black and moved on to the next section.  Using a different colour font helped me to prioritise those sections of the study guide.


     3.  Be specific

After a while you can lose the will to live whilst completing the endless sections of the application form.  It therefore becomes easy to write generic statements in an attempt to rush the process.  The assessors reading your application form will be looking for details of what you actually did.

For example: which statement would best demonstrate to the assessor your knowledge on supplier audits? 
 - Perform supplier audits
 - Performing a supplier audit on a media manufacturer who supplies my organisation.  The audit included a  review of the supplier's ISO9001 certified QMS, media manufacturing processes & facilities.

     4.  Know your dosage form

The contents of your application form will dictate some of the lines of questioning from the assessors.  This will be particularly important when it comes to your specified dosage form.  You obviously wont be expected to know every dosage form but you'd better know all the ones you put down on your form - especially those other dosage forms on your MIA license. 

Summary

The application form is a critical part of your application process and will provide the assessor's a first impression of you and your potential to be a QP.  Completing the form takes time and I would highly recommend starting as soon as possible.

Thanks to my sponsor for help with this article and for reviewing my own application form!

Study Toolbox Part 4: Training Courses

This 4th post in the Study Toolbox series will provide an overview of the training courses available to help you on your long road to eligibility. 

One of my previous posts gave a brief overview of the QP Study Guide which provides a general syllabus that all prospective QPs are expected to have a detailed understanding of.  There is a wealth of topics within the Study Guide and the breadth of topics can be overwhelming at first glance.  This may be of particular relevance for trainee QPs from either small scale manufacturing operations (like me) or from those from relatively niche areas such as  PET radiopharmaceutical or medical gas manufacture.

So how can you demonstrate you have the required knowledge & experience in all 11 sections of the Study Guide?   The training providers listed below will provide this but they are not compulsory or expected to be on your application form.

Commercial Training Providers

Training courses are one way of gaining sufficient knowledge.  The main commercial training providers offer modules based on each of the 11 sections of the Study Guide.  These courses not only provide comprehensive training but also provide a fantastic opportunity for networking with other trainee QPs.  This is especially important for identifying potential study partners and arranging reciprocal visits.  (I'll aim to cover visits in a future post).

NSF-DBA

The David Begg Associates courses have been running for a number of years now and are viewed by many to be the gold standard with regards to QP training packages.  The full course is linked with the University of Strathclyde and offers candidates the opportunity to gain a post graduate certificate, diploma or MSc.  The modules run over 21 months but you can pick and choose the modules to fit in with your own requirements or knowledge gaps.

Each module lasts between 4 to 5 days in Durham or York Marriott hotel conference centres.  Lecture notes for each module are substantial and include not only the slides but a very useful overview of each lecture in an easy to read format that compliments the slides really well.  The week long course is broken up into lectures and practical group work.  Written exams are held for those students aiming to complete the post graduate university course.

Is there a downside?   At circa. £3-4k per module the cost my be prohibitive for some companies or individuals who are self-funding (like me).  Also the length of the course means added expense of hotel & travel.  DBA offer special rates for the Marriott hotel at circa. £100 per night and will obviously provide a great platform to continue the networking into the early hours!   

DBA does offer a generous 50% discount for NHS employees which then brings it the price down in line with other providers.  To qualify for the discount you'll need a confirmation letter from your employer and DBA will then invoice you with the discount included.

DBA also offer a free annual QP training day for prospective students and their sponsors.  The date for this year is May 14th and I'll be heading up for the day.  It might be worth contacting DBA directly to enquire for last minute availability.

RSSL

RSSL specialise in scientific analysis, consultancy, product development and training for the pharmaceutical and food sectors.  Their popular QP training packages offer the similar layout to DBA by offering 11 stand alone modules the reflect the Study Guide.  There is no university collaboration so post graduate qualifications are not available to run in parallel with the QP course.

RSSL has its advantages over DBA.  The training is held within Reading and typically over 2 days meaning less impact to your work and family duties and may not require nights away from home for those based around London.   The costs per module is more accessible at circa £1.5k.  The shorter duration of the module means more of a focus on the relevant details required for your QP training.  The notes are more succinct than DBA but do not provide the excellent text overview for each lecture.   

Inspired Pharma

Inspired Pharma offer an alternative platform with their QP training.  They provide online tutor-facilitated courses on the Study Guide topics.  This allows you to fit the training in and around your busy work/life schedule without the need to spend 3-5 days on a residential course.  There is not a great deal of information on their website regarding the costs of these courses but I would suggest emailing them for further information.

Pharmaceutical Quality Group

Although not strictly a QP training provider, the PQG is an invaluable source of information for trainee QPs.  Membership is only £17 per year and this provides access to a wealth of documents and presentations available via their website.  For trainee QPs the PQG provide QP seminars specifically aimed at trainees and newly qualified QPs.  These full day seminars based in London provide a great introduction to QP training.  They cover the application process, requirements and legislation/GMP update session.  

My first foray into the QP training arena was attending last year's November seminar.  I found it extremely useful and a great opportunity for networking with other trainee QPs from the pharmaceutical industry.  I met a great study partner from this course and we still have weekly calls to discuss scenarios etc. 

The PQG also arrange visits to a wide range of pharmaceutical manufacturing facilities, distributors, API manufacturers.  The events page on their website gives all the visits coming up.  These are particularly good value at around £60 per visit. 

Non-Commercial Training Providers

Q3P (UCL School of Pharmacy)
 
This is the only non-commercial provider that I am aware of.  The Q3P course was initially aimed at addressing the shortage of QPs within the NHS sector.  The course is free for NHS staff and provides a similar layout to the commercial providers in following the Study Guide with 1 or 2 day modules.  Although still in its infancy the course is now enrolling its 3rd cohort.  The training has evolved since the first cohort and includes lecturers from both the pharmaceutical industry and NHS sectors as well as QP assessors. 

The Q3P course has a free open day on the 6th June 2013 for prospective students.  See their website for details.

Post Graduate University Courses

There are a number of university courses that cover some aspects of the Study Guide.  Although not specifically tailored to QP training they do offer a good grounding in the essential elements of pharmaceutical manufacturing & quality assurance.  These part time courses are designed on a modular basis and will provide the opportunity for post graduate qualifications to MSc level.  Post graduate qualifications are available with the NSF-DBA course (see above).

PIAT (Manchester University)
Industrial Pharmaceutical Sciences (Brighton University)
Pharmaceutical Technology (Bradford University)
PTQA (Leeds University)
Leeds University has now stopped supporting the PTQA course and currently there is no further information on the future of the course.

Completion of these courses would usually be expected before gaining QP trainee positions.  From there the QP trainee would often be sent on the specific commercial training courses to build on the knowledge from the post graduate course. 


Individualised Mentoring & Training

All of the courses above will provide you with a great amount of knowledge covering all aspects of the Study Guide.  However it must be noted that attendance to these course wont automatically get you through the viva.  The knowledge gained wont provide you with the detail and expertise required to structure well reasoned responses to the viva questions. 

This is where personalised training will help translate your knowledge into a well structured format to get you through the viva.  They will also offer to review your application form and provide either face-to-face or telephone training sessions tailored to suit you and your specific requirements.  The providers will also be well networked within the QP community and hence should be able to provide contacts for potential visits.

QPQuandary

This personalised training company provides coaching and mentoring to both QP trainees and sponsors.  It is run by Alex Hall who provides teaching on some of the commercial training courses including RSSL & Q3P as well as one-to-one coaching.

Alex is the RSC Chief Assessor and senior QP for Roche, but will be running QPQuandary full time in the near future. Therefore she knows what it takes to get through the viva and can provide mock vivas, application form reviews and numerous other services to help meet your training needs. In addition she provides a fantastic weekly teleconference service for groups of QP trainees from a wide range of backgrounds. For more information see the QPQuandary website for her contact details.


Other Training Sources

Self Study

Your own personal study underpins everything you learn both from your job and attendance at training courses.  There are no shortcuts.  You will have to hit the books for hour after hour to ensure all the knowledge remains at the forefront of your mind especially leading up to viva day.  Self study is acceptable for inclusion into your application form.

In House Training

Some of the larger companies (e.g. GSK) provide substantial in-house training programmes for trainee QPs that rival even the DBA course.  For those with shallower pockets in house training can be provided by your sponsor or from subject matter experts within your company.  This can be on a one-to-one basis or as part of departmental-wide training sessions. 

My own training plan

My training is underpinned by a Pharmacy degree and  post graduate diploma in the PTQA course.  I've chosen a pick n' mix selection from the training providers in order to fill in the gaps.  A gap analysis really helps identify those areas that need supplementing with training courses.  I'll be using DBA for API manufacture, roles of QP and Law & Administration courses this year.  Law & Admin and QP roles are essential as they form the majority of the fundamental modules of the Study Guide.  API manufacture is not something I have exposure to from either work experience or from my previous training courses and hence is a significant knowledge gap for me.  In addition to these I've booked a mock viva & mentoring sessions with QPQuandary as a milestone for me prior to submitting.  I've also got into the habit of self study most evenings to supplement all the above.

 Summary

There are a wide range of QP training courses available to cater for all your training requirements.  They are not compulsory for getting to the viva but will provide you with the knowledge, networking and confidence in new subject areas.   Supplementing these with one-to-one coaching sessions either from your sponsor or specialist training providers should provide the final polish for you before you enter the lions den.

I'm sure there are other providers out there.  Please add any to the comments section below.


Study Toolbox Part 1:  The Onion
Study Toolbox Part 2:  Introduction to Mindmaps 
Study Toolbox Part 3:  Keeping up to date