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

Quality by Design principles are at the forefront of pharmaceutical development, delivering new, high-quality medicines for patients. This course enables scientists and pharmacists to enhance and develop their skills and capabilities in pharmaceutical process, healthcare and product development.

Chat with us online at our Postgraduate Online Chat on Wednesday 28 October Book now

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)


Designed to meet the professional development needs of pharmaceutical and allied practitioners worldwide, this course provides the tools and techniques needed to implement a Quality by Design approach within your own organisation. This course is delivered entirely through flexible distance learning, allowing you to study alongside your career.

On this programme you will benefit from our strong industry links with leading industrial and regulatory experts such as Pfizer, AstraZeneca, GlaxoSmithKline, and the Medicines and Healthcare products Regulatory Agency. Insight and support from guest lectures and other experts within the sector mean that your studies are up to date with current practice and developments within the field. 

Our programme and module leaders are all registered pharmacists who bring a wealth of experience of working in hospitals, the community, primary care and pharmacy practice to the course. With a variety of core and optional modules available, along with flexible exit routes, you can tailor your studies to your career and interests.

Key features

  • We have an established reputation of more than 100 years in pharmacy teaching.
  • Learn from a dedicated team of staff who are all registered pharmacists with experience in hospitals, the community, primary care, secure environments and pharmacy practice.
  • Undertake a range of core and optional modules including; Quality by Design, Manufacturing, Process Controls and Inspection and Research Methods.
  • Benefit from flexible exit routes to obtain either a MSc, PG Dip or PG Cert.
  • Career opportunities exist in product development, manufacturing, regulatory affairs, marketing and clinical research.

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 2021 (20/21 entry) and October 2021 (21/22 entry)

Location of study: Distance Learning

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

2020/21 Part-time tuition fees will be £1,100 for 15 credits, £1,525 for 30 credits and £2,200 for dissertation

2021/22 Part-time tuition fees will be £1,150 for 15 credits, £1,575 for 30 credits and £2,250 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 2021 (20/21 entry) and October 2021 (21/22 entry) 

Location of study: Distance Learning

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

2021/22 Part-time tuition fees will be £1,150 for 15 credits, £1,575 for 30 credits and £2,250 for dissertation

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.

Purpose-built clinical skills areas allow you to practice in a safe environment. You will receive guidance and support from staff to ensure that you develop a precise and accurate practical ability in the clinical skills suites.

Library services

On campus, the main Kimberlin Library offers a space where you can work, study and access a vast range of print materials, with computer stations, laptops, plasma screens and assistive technology also available. 

As well as providing a physical space in which to work, we offer online tools to support your studies, and our extensive online collection of resources accessible from our Library website, e-books, specialised databases and electronic journals and films which can be remotely accessed from anywhere you choose. 

We will support you to confidently use a huge range of learning technologies, including Blackboard, Collaborate Ultra, DMU Replay, MS Teams, Turnitin and more. Alongside this, you can access LinkedIn Learning and learn how to use Microsoft 365, and study support software such as mind mapping and note-taking through our new Digital Student Skills Hub. 

The library staff offer additional support to students, including help with academic writing, research strategies, literature searching, reference management and assistive technology. There is also a ‘Just Ask’ service for help and advice, live LibChat, online workshops, tutorials and drop-ins available from our Learning Services, and weekly library live chat sessions that give you the chance to ask the library teams for help.

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

These events are a great way for you to find out more about postgraduate study at DMU.  

See when our upcoming events are taking place. 

Book now

Order a prospectus

Our prospectus will give you a clearer idea of what it's like to live and study at DMU and a snapshot of the courses we offer.

Order your copy

How to apply

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

Find out more

More about your DMU

50% off selected PG courses
Research at DMU
PG events
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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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Research

The Leicester Institute for Pharmaceutical Innovation (LIPI) is a hub for the research of the Leicester School of Pharmacy. The institute’s research focuses on the study of medicines and healthcare products and services, while delivering education and training for those working in these fields.  

Our work addresses the development of drug delivery and manufacturing processes, analytical and forensic sciences and toxicology. We study the pharmacological activity of drugs, substances and medical devices and their therapeutic uses, clinical applications, and interactions with biological systems and the environment.

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Online chats

The best way to find out more about DMU is to attend one of our virtual postgraduate events. Get all the answers to your questions through an online chat with our student and staff advisers, or check out our postgraduate live stream schedule for programme specific talks, to find out how our courses can enhance your knowledge and benefit your career path.

These virtual events are a chance to learn more about our extensive careers and employability support, and find out about fees and funding opportunities, including our VC2020 scholarship which offers up to 50 per cent off PG study, and sports scholarships of up to £6,000. You can also take a tour of our beautiful campus and facilities from the comfort of home via our Virtual Open Day.

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Events

The best way to find out more about DMU is to attend one of our virtual postgraduate events. Get all the answers to your questions through an online chat with our student and staff advisers, or check out our postgraduate live stream schedule for programme specific talks, to find out how our courses can enhance your knowledge and benefit your career path.

These virtual events are a chance to learn more about our extensive careers and employability support, and find out about fees and funding opportunities, including our VC2020 scholarship which offers up to 50 per cent off PG study, and sports scholarships of up to £6,000. You can also take a tour of our beautiful campus and facilities from the comfort of home via our Virtual Open Day.

 
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At DMU there is always something to do or see, check out our events for yourself.

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Discover the DMU campus
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Take a look around DMU by exploring our Virtual Open Day.