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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.


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)


At DMU, we are committed to helping our graduates enhance their careers and personal development through further study. We are proud to currently offer two scholarships.

Vice-Chancellor’s 2020 Scholarship
Up to 50 per cent of tuition fees offered to Home/EU DMU alumni for students who wish to continue their studies at DMU by enrolling on a Postgraduate taught course. For more information visit our Vice-Chancellor’s 2020 Scholarship page.

Vice-Chancellor's Sports Scholarship
Up to £6,000 worth of support available to full-time UK and EU undergraduate and postgraduate students, starting in September 2016. For more information visit our Vice-Chancellor's Sports Scholarship page.

More courses like this:

Pharmaceutical Quality by Design

Advanced Biomedical Science

Pharmaceutical Biotechnology

Clinical Pharmacy Distance Learning

Contact details

E: or (Dr W Schlindwein, Programme leader)
Admissions Department
De Montfort University
Edith Murphy House, Room 0.23
The Gateway


  • UK/EU
  • International

Key facts for UK/EU students

Institution code: D26

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

There are two intakes per year, in April and September.
The next Induction days will be 12, 13 or 14 April 2016. Dates will be allocated upon acceptance of an offer.
The first study day will be 18, 19 or 20 May 2016. Dates will be allocated upon acceptance of an offer.
Future study day dates will be confirmed on commencement of the course.

Location of study: Distance Llearning

Fees and funding: Fee information table

Find out more about course fees and available funding.

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

How to apply: International students can apply to study at DMU directly using our online portal or by submitting a direct application form.

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


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Not available to international students.

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 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 - provides the fundamental concepts and tools applied to pharmaceutical product design, process design, process monitoring and continuous verification based on Quality by Design principles
  • The QbD Product Development Roadmap - 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 biophamaceutics and excipient properties
  • Quality by Design in Practice - explores 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 - focuses on 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 are evaluated from the perspectives of author, assessor and GMP inspector
  • Negotiated Studies - offers the 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 - introduces 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 - 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 registeredpharmacists, 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 facilties

Investment of £12 million in Health and Life Sciences has developed our first-class teaching and learning facilities to help you develop your practical experience and theoretical knowledge beyond the classroom.

Learn more about DMU’s first-class study facilities.

Library services

We have 1,500 study places and 650 computer workstations across four sites on campus. These give access to more than half a million publications, an extensive range of DVDs, e-resources and thousands of electronic journals. 

The main Kimberlin Library is open 24 hours a day, 365 days of the year (other than in exceptional circumstances).

Award-winning staff are on hand to help and there is a café for study breaks. We offer a range of workshops, drop-in and one-to-one sessions, and our Just Ask service provides email and telephone support.

Learning zones

Our comfortable and well-equipped study areas provide a range of environments to suit your needs.

Originally set up in our main Kimberlin Library, the learning zones proved so popular that more were created in the Eric Wood Building and Greenhouse. These flexible spaces are ideal whether you are working as a group, practising a presentation or working quietly on your own.

They feature workstations with power supplies for laptops, plus bookable syndicate rooms with interactive whiteboards and DVD players. Eduroam wi-fi is available across all campus locations.

Opportunities and careers



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 >


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.


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

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More about your DMU

50% off selected PG courses
Open evenings
Online chats
Research at DMU

50% off selected PG courses

We are committed to helping our graduates enhance their careers and personal development through further study, which is why we offer the Vice-Chancellor’s 2020 Scholarship. This gives DMU graduates a tuition fee discount of up to 50 per cent on selected full-time and part-time postgraduate courses, based on academic achievement and merit. Find out more.


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.


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.


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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