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Quality by Design for the Pharmaceutical Industry MSc/PG Dip/PG Cert

Quality by Design (QbD) is at the very heart of leading edge pharmaceutical development, with QbD-based regulatory submissions continuing to rise and principles being embedded in development processes across the pharmaceutical industry.

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Overview

Apply here for the Medical Leadership, Education and Research Skills programme

If you are experiencing problems with the online admissions portal, or would prefer to apply using a paper form, please download the attached form, returning the completed form to HLS Admissions by email (hlsadmissions@dmu.ac.uk)

The course will significantly help the scientists of today and tomorrow build their capabilities in delivering high quality innovative medicines for patients; potentially leading to careers in leading companies such as AstraZeneca and GlaxoSmithKline.

Reasons to study Quality by Design for the Pharmaceutical Industry at DMU:

  • Designed to meet the continuing professional development (CPD) needs of pharmaceutical and allied practitioners worldwide, it provides the tools and techniques needed to implement a QbD approach within your own organisation
  • Study a range of specialist modules through flexible distance learning, with opportunities to undertake stand-alone modules leading to a named CPD award
  • Our strong links, direct input and guest lectures from by leading industrial and regulatory experts such as Pfizer, AstraZeneca, GlaxoSmithKline and the Medicines and Healthcare Products Regulatory Agency ensure your learning is relevant to current practice and developments within the sector
  • Our experienced practitioner- and research-based academic staff have recently received grant-funded collaborative research and development to improve industrial process quality and efficiency, with Innovate UK (formerly TSB) and the Engineering and Physical Science Research Council (EPSRC)
  • Become a graduate of the highest calibre - we have an established reputation of more than 100 years in pharmacy teaching
  • Course content informs part of a major initiative, being driven and supported by US, EU and Japanese regulatory authorities, and defined within the Q8, Q9 and Q10 Guidelines from the International Conference on Harmonization (ICH)

More courses like this:

Pharmaceutical Quality by Design

Advanced Biomedical Science

Pharmaceutical Biotechnology

Clinical Pharmacy Distance Learning

Contact details

E: qbd@dmu.ac.uk or wss@dmu.ac.uk (Dr W Schlindwein, Programme leader)
Admissions Department
De Montfort University
Edith Murphy House, Room 0.23
The Gateway
Leicester

 

  • UK/EU
  • International

Key facts for UK/EU students

Institution code: D26

Duration: part-time (minimum two years, maximum six years)

Attendance:
There are two intakes per year, in April and October.

Start dates: April 2020 (19/20 entry) and October 2020 (20/21 entry)

Location of study: Distance Learning

Fees and funding: For 2020/21 full-time tuition fees will be £8,975

Part-time tuition fees will be £1,100 for 15 credits, £1,525 for 30 credits and £2,200 for dissertation

Find out more about postgraduate course fees and available funding.

Find out more about the Vice-Chancellor's Sports Scholarships worth up to £6,000.

Find out more about additional costs and optional extras associated with this course.

Please visit dmu.ac.uk/international for more information or call us on +44 (0)116 2 50 60 70.

 


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Key facts for UK/EU students

Institution code: D26

Duration: part-time (minimum two years, maximum six years)

Attendance: 
There are two intakes per year, in April and October.

Start dates: April 2020 (19/20 entry) and October 2020 (20/21 entry)

Location of study: Distance Learning

Fees and funding: For 2020/21 full-time tuition fees will be £8,975

Entry criteria

  • A good honours degree (minimum 2:2 or equivalent) in a chemical, biological or physical science, including (though not exclusive to) chemistry, biology, chemical engineering, engineering, pharmacy, pharmaceutical science, or physics (or equivalent)
  • Alternatively, we will accept a portfolio of professional and/ or academic qualifications of equivalent standing to an honours degree
  • Students should ideally be employed within the pharmaceutical or health sectors

English language requirements:

If English is not your first language an IELTS score of 6.5 or equivalent when you start the course is essential. English language tuition, delivered by our British Council accredited Centre for English Language Learning (CELL), is available both before and during the course.

Please visit dmu.ac.uk/international for more information.

 

Structure and assessment

 

Course modules

Teaching and assessment

Academic expertise

 

Course modules

Undertake a range of core and optional modules, with flexible exit routes as MSc, PG Dip and PG Cert. You can also choose to study a stand-alone module through the Continuing Professional Development (CPD) route (please contact us for more information).

Modules include:

  • Regulatory Guidelines, Principles and Tools of Quality by Design (30 credits)  - In this module the work-based learners are introduced to the core of the QbD framework, including quality target product profile (QTPP), product and process development (critical quality attributes - CQAs and critical process parameters - CPPs), API development, design space, control strategy and continuous improvement. These principles are underpinned by science, pharmaceutical quality systems, quality risk management and knowledge management. 
  • The QbD Product Development Roadmap (30 credits) - This module uses the QbD process flow or roadmap to illustrate the start to end product development process.  The recorded lectures cover key areas which impact product or process design such as biopharmaceutics and excipient properties.  The aim of this module is to demonstrate how QbD principles are applied throughout the different stages of product and process development.  Key QbD tools, such as risk assessment are demonstrated through examples and case studies.
  • Quality by Design in Practice (30 credits) - This module will draw on practical examples of the application of QbD principles across a diverse range of product types such as inhalation, sterile product and biopharmaceuticals.  The use of QbD principles in analytical method development will also be covered.  This module aims to help learners identify how they can apply QbD principles in their work environment.
  • Manufacturing, Process Controls and Inspection (15 credits) - This module presents the elements of quality by design used in manufacturing, including advanced process controls as applied to both batch and continuous processing. Practical aspects of a QbD submission will be presented from the perspectives of author, assessor and GMP inspector.
  • Negotiated Studies (15 credits) - The module aims to offer students an opportunity to formulate, present and implement an individual proposal for a study, investigation or exploration in an area of professional relevance and interest.
  • Research Methods (15 credits) - The module aims to introduce some generic research design principles and research methods in order to provide a thorough grounding in scientific areas of research, from experimental design, through data collection and presentation of data, to data analysis and the writing up of research results.
  • Dissertation (60 credits) - This module provides each student with an opportunity to consolidate their knowledge of quality by design applied to pharmaceutical development by carrying out a research or development project in an area directly related to pharmaceutical product design, development or manufacturing.

Teaching and assessment

Course material is delivered through video lectures with integrated presentations, and utilises a variety of course assessment methods including; reflective writing, case study analysis, critical review of literature and a research project. Each module is studied over 20 weeks, while the dissertation is designed to take.

 

 

Academic expertise

We have a dedicated team of staff who contribute to the course. The programme and module leaders are all registered pharmacists, and have experience in the hospital, community, primary care, secure environment and prescribing areas of pharmacy practice.

MSc supervisors are drawn from the Leicester School of Pharmacy and local community and hospital pharmacists who can support you in your project. We also use a team of expert pharmacists and doctors who contribute to the development of the course material and assessments on the study days.

Facilities and features

Health and Life Sciences facilities

Substantial investment has developed our teaching and learning facilities to help you expand your practical experience and theoretical knowledge beyond the classroom. 

The 19th century Hawthorn Building has facilities designed to replicate current practice in health and life sciences, including contemporary analytical chemistry and formulation laboratories, audiology booths and nursing and midwifery clinical skills suites. 

Our state-of-the-art laboratories allow you to gain experience in a safe environment. You will receive guidance and support from academics and technicians to ensure that you develop a precise and accurate practical ability. As well as laboratories that are designed to replicate current practice, they are equipped with industry-standard apparatus so that you are able to leave University work-ready.

Library services

The main Kimberlin Library is open 24 hours a day, 365 days a year (other than in exceptional circumstances) and offers a huge range of online resources, all of which can be remotely accessed from anywhere you choose.

The library is run by dedicated staff who offer additional support to students, including help with academic writing, research strategies, literature searching and reference management and assistive technology, and mathematical skills for non-maths students. There is also a Just Ask service for help and advice, available via email or telephone.

Learning zones

Our Learning Zones and The Greenhouse also provide space for group or individual work and study.

There are 1,600 study places across all library locations, more than 700 computer stations, laptops to borrow, free wi-fi and desktop power outlets.

You can also book rooms with plasma screens, laptops and DVD facilities for group work and presentations, secure an individual study room with adjustable lighting or make use of our assistive technology.

Opportunities and careers

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Scholarships

As part of the university's commitment to enhancing the personal and career development of our graduates. We offer an Alumni scholarship programme. For more information visit Health and Life Sciences Alumni Scholarships.

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Graduate careers

This course equips graduates with the relevant knowledge and skills to compete for global jobs in the pharmaceutical, healthcare sectors and academia. Career opportunities exist in product development, manufacturing, regulatory affairs, marketing and clinical research.

 

DMU Open Evenings

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How to apply

We welcome applications from students with a wide range of qualifications and experience.

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More about your DMU

50% off selected PG courses
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50% off selected PG courses

If you’ve completed an undergraduate degree at DMU, then you can benefit from a tuition fee discount of up to 50 per cent on our postgraduate courses. The discount is available on selected full-time, part-time and distance learning postgraduate courses running across multiple start dates. 

The discount, based on academic achievement and merit, applies automatically to all DMU UK and EU students who are graduating this year or have graduated within the past two years and achieved a 2:1 (or equivalent) or above. Learn more here.

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Open Evenings

The perfect way to find out more about DMU is to attend one of the postgraduate open evenings or events that take place all year round. If you can't visit the university in person, you can also sign up for one of our online chats. Find out more.

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Online chats

If you are unable to visit the university in person, we hold regular events where you can chat online with an adviser. Find out more.

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Research at DMU

De Montfort University (DMU)’s growing reputation for research which benefits society has been confirmed with the publication of the REF 2014 results. Find out more.

 
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