<Qualified Person> <FAQs>

Qualified Person - FAQs

FAQs From The Delegate's Perspective

Do I need the backing of my company to start the QP course?
Do I need to be a member of my professional body?
How much and what practical, industry experience do I need to become a QP?
Do I need to gain the necessary 2 years (1 year for Pharmacists) practical experience before I enrol?
How often will I be away from home and work while I train?
What professional and career benefits will I gain by becoming a QP?
How much additional study is there?
I'm not sure I have a "relevant" degree, how can I find out where I stand?
Which modules do I need to attend to become a QP?
What are the advantages for me if I do this residential course instead of distance learning?
What are the current David Begg Associates and University of Strathclyde success rates?
When can I start my training?
How do I sign up?

FAQs From The Company's Perspective

How much commitment is required from the company for QP training?
What if we train a QP for our company and they leave?
Why do we need a QP in our company/on our site?
What benefits will a QP bring to our company?
Why don't we hire a locum QP instead?
Why choose DBA QP training for our company?
How often will our employee be away from work?

Do I need the backing of my company to start the QP course?
David Begg Associates strongly encourage prospective QP delegates to gain the full support of their company; not just for financial reasons but also from an emotional perspective, for sponsorship, time off work and assisting with gaining valid practical experience.

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Do I need to be a member of my professional body?
It is not compulsory to be a member of your relevant professional body but we strongly advise it as they will provide you with assistance in completing the application for your viva and give you support throughout your career.
Contact details of the three UK professional bodies are as follows:-

The Society of Biology
9 Red Lion Court
London EC4A 3EF
Tel: 020 7936 5934
Fax: 020 7936 5935
E-mail: [email protected]
Contact: Cliff Collis

The Royal Society of Chemistry
Burlington House
Piccadilly
London W1V 0BN
Tel: 020 744 03383
Fax: 020 728 79825
E-mail: [email protected]
Contact: Jane McLauchlin

The Royal Pharmaceutical Society of Great Britain
1 Lambeth High Street
London SE1 7JN
Tel: 020 7572 2406
Fax: 020 7582 3401
E-mail: [email protected]
Contact: Rachel Norton

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How much and what practical, industry experience do I need to become a QP?
Experience in general manufacture and quality control must be undertaken in fully licensed premises of a manufacturer of medicinal products. Fully licensed means in possession of a manufacturers licence (ML). A "Specials" licence does NOT fulfil this requirement. Normally the practical experience extends over two years for a Biologist or Chemist, or one year for a Pharmacist. There are exceptions to these requirements for degrees lasting five or six years.

Obviously the more practical experience gained working in the Pharmaceutical Industry the better for you!

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Do I need to gain the necessary 2 years (1 year for Pharmacists) practical experience before I enrol?
The practical experience needs to be gained before a candidate goes forward for final assessment to become a QP so delegates can enrol without having gained this experience and can train with David Begg Associates while gaining the practical experience on their site at the same time.

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How often will I be away from home and work while I train?
Each module lasts for a maximum of five days running from Sunday evening until Friday afternoon. The reason for the Sunday evening start is to allow delegates to sit exams for the previous module if they attended it.

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What professional and career benefits will I gain by becoming a QP?
The QP is a recognised Quality Professional with a broad knowledge base and with experience in applying the knowledge to pharmaceutical QA situations. With his knowledge of EU law the QP is an information resource to colleagues and his company, often becoming an expert contact with the regulatory bodies.

There is an increasing requirement for QP training for jobs in Quality and Production management and in the inspectorate.

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How much additional study is there?
The advantage to doing QP training through a residential course like David Begg Associates means that all the study necessary is undertaken during the module and there is very little pre or post module learning required.

However, if a delegate intends to sit the modular examinations which are carried out at the beginning of the following module, there will be some reading of the course notes required as revision.

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I'm not sure I have a "relevant" degree, how can I find out where I stand?
In the vast majority of cases a delegate will be qualified (by degree, or equivalent) in Biology, Chemistry, Microbiology or Pharmacy. However, it should be noted that under the permanent provisions, degrees (or equivalent) in medicine, veterinary medicine, pharmaceutical chemistry and technology are also eligible.

If you are not sure about your degree you can contact David Begg Associates in the first instance and we will be able to advise you.

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Which modules do I need to attend to become a QP?
You can attend any module out of the 12 that you feel you need to. There is no set number. The only exception is if you are planning on doing the Diploma. In this instance you will need to take 11 modules and maybe allowed one exemption.

Many delegates are unsure of the particular modules that they need to attend and often look to David Begg Associates for advice on how our training will fit in with the qualifications they already have and the experience that they have gained. We provide a "gap analysis" which can either be done by correspondence or via a visit to our offices or your site. Contact us for further information.

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What are the advantages for me if I do this residential course instead of distance learning?
David Begg Associates firmly believe that there is no substitute for face-to-face learning in a classroom environment - our success rate proves this! Residential training enables you to exchange views and experiences and to learn from your fellow students as well as from the tutors away from the distractions of home and work.

Guided learning enables the candidates to focus on the critical subject information and learn to apply the knowledge to true to life situations.

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What are the current David Begg Associates and University of Strathclyde success rates?
By the end of Series 9 in June 2008 we are pleased to announce that over 182 of our former delegates had become QP's - a success rate of 95% at viva.

Just under 50 people have passed the Post Graduate Diploma in Pharmaceutical Quality and Good Manufacturing Practice and the success rate is 98%. Four people have attained the MSc and the success rate is 100%.

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When can I start my training?
Delegates can join at any point during the training course as each module is designed to be stand alone. This enables you to better fit your training around your home and work life.

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How do I sign up?
Contact David Begg Associates either by:
Telephone: +44 (0) 1751 432999 or
E-mail: [email protected] and speak to Stella Pearson-Smith our QP Administrator.

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How much commitment is required from the company for QP training?
A company needs to provide financial backing, assist with practical experience, sponsorship, and emotional support.
It is a big responsibility enrolling an employee onto QP training however the benefits and rewards to a company are huge.

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What if we train a QP for our company and they leave?
That is always a risk but you also need to ask yourself - what if you don't train them and they stay!

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Why do we need a QP in our company/on our site?
According to the EC Directive 2001/83, pharmaceutical products can only be released onto the European market by a QP named on the licence. In addition, QP training is the best way of developing staff knowledge and ability and to apply knowledge in a quality based environment.

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What benefits will a QP bring to our company?
The QP is highly trained in a broad range of subjects. This broader experience and knowledge will help in day to day real life problem solving as well as longer term continued improvement.

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Why don't we hire a locum QP instead?
This option can be satisfactory for some smaller companies, however, a staff based QP will undoubtedly have a greater commitment and ability to become aware of all the key issues in an organisation.

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Why choose DBA QP training for our company?
We have trained more QP's than all the other training providers put together and our success speaks for itself.
We believe that our success is due in no small part to the face-to-face training, the practical focus and the personal attention that we provide to each and every one of our students.

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How often will our employee be away from work?
This is very dependent on how many modules out of the 12 your candidates needs to attend. Working on the basis that they need to attend all of the modules they would be away from work for 5 days every 6-8 weeks.

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