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Quality by Design for the Pharmaceutical Industry MSc/PG Dip/PG Cert/CPD - Distance Learning

The science and risk-based approach to pharmaceutical development and manufacturing technologies.

Overview

Quality by Design is “a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” (ICH Q8)

This course provides a structured approach to explore the development of a risk-based, data driven control strategy for the manufacture of pharmaceutical products and processes.

All lectures are delivered by experts from industry using our online platform. You can access the learning material at anytime from anywhere in the world.

There are two intakes a year for this programme – April and October.

Student support and access to learning material is all online.

The course aims to improve your approach to pharmaceutical product development and enhance your employability skills and career prospects.


Who should attend the course?

This course has been designed for graduates and postgraduates (biologists, chemists, chemical engineers, pharmacists, physicists, material scientists) who aspire to learn more about developing and manufacturing medicines using Quality by Design principles.


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

  • High employability
  • Job opportunities nationally and internationally
  • Aligned with international regulatory framework
  • Recognised by multinational companies

The opportunity of learning from several industry experts in each module is unique. Add to that great support from the DMU professors, a distance learning platform that works well and you end up with a complete learning experience.

Vinicius Steffen (October 2019 intake) is part of the Technical Services team of BASF Pharma Solutions in South America

  • UK/EU
  • International

Key facts for UK/EU students

Institution code: D26

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

Start dates: April 2021 (20/21 entry) and October 2021 (21/22 entry)

Location of study: Distance Learning online

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

Contact details: Email qbd@dmu.ac.uk or wss@dmu.ac.uk (Dr W Schlindwein, Course Director)

Key facts for international students

Institution code: D26

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

Start dates: April 2021 (20/21 entry) and October 2021 (21/22 entry)

Location of study: Distance Learning online

Fees and funding: 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

Contact details: Email qbd@dmu.ac.uk or wss@dmu.ac.uk (Dr W Schlindwein, Course Director)

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 structure

Teaching and assessment

 

Students have the option to complete PGCert, PGDip or MSc awards. Alternatively, every module is available as a bite size ‘Continuous Professional Development’ (CPD) module.

PG Certificate

  • Regulatory Guidelines, Principles and Tools of Quality by Design (30 credits)
  • The QbD Product Development Roadmap (30 credits)

After completing 60 credits, students will receive a Postgraduate Certificate in QbD for the Pharmaceutical Industry.

PG Diploma

  • Quality by Design in Practice (30 credits)
  • Manufacturing, Process Controls and Inspection (15 credits)
  • Negotiated Studies (15 credits) optional
  • Research Methods (15 credits)

After completing 120 credits, students will receive a Postgraduate Diploma in QbD for the Pharmaceutical Industry.

MSc

  • Dissertation (60 credits)

Students who wish to study towards a MSc award need to study the Research Methods module. They will receive a MSc degree in QbD for the Pharmaceutical Industry after completing 180 credits.

Read more detailed module information

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. Students can pace their learning to suit individual timeframes, within the suggested timeline of 20 weeks per module, while the dissertation is designed to take 40 weeks.  The lectures are delivered by industry professionals, all from leading companies.

 

 

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Our course brochure will explain what it's like to study Quality by Design for the Pharmaceutical Industry at DMU

Download brochure

Online resources

 

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.

Opportunities and careers

Winner: Best University Careers and Employability Service
NUE Awards, 2021
Learn more
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This course will enable students to:

  • Learn how the different elements of Quality by Design fit together in practice
  • Appreciate how QbD supports customer-focussed process, product development, and manufacture
  • Gain understanding of a pragmatic risk-based and data-driven approach
  • Identify the ICH terminology (QTPP, CQA, CPP etc) and gain a deep understanding of implementation in case-studies
  • Apply Quality Risk Management including risk identification and risk-ranking tools
  • Grow your experience of sequential experimental design: screening, optimisation, robustness, verification to gain information from data
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Develop skills for careers in:

  • Pharmaceutical R&D and Manufacturing organisations, including those developing novel or making generic products
  • Contract Manufacturing, and ‘virtual’ companies
  • Scientists, analysts, development, production, engineers, and support functions such as validation, Chemical processes and products, including Active Pharmaceutical Ingredients (API) and intermediates, food, and consumer health care

This is an excellent distance learning program for professionals who want to expand their expertise and create a network in this field. The course material was comprehensive and tutors and other students attending were very easy to get in touch with. The flexible time for studying is definitely a must for people who need to manage other commitments and cannot afford to go back to full-time studying

Bozena Adamczyk - Vice President, Scientific Project Leadership, Integrated Development Programs at Evotec, Italy

DMU Open Evenings

The perfect way to find out more about DMU is to attend one of our postgraduate open events.

Here, you can speak with course academics and current students, discuss fees, learn about your career prospects and tour the campus.

Book now

Download a course brochure

Our course brochure explains what it's like to study Quality by Design for the Pharmaceutical Industry at DMU.

Download now

How to apply

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

Find out more

More about your DMU

About De Montfort University
About Leicester School of Pharmacy
About Quality by Design at DMU
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About De Montfort University

De Montfort University (DMU) is a dynamic institution with a long and vibrant history of improving people’s lives through education. Originally founded as the Leicester School of Art in 1870, the university has evolved through many incarnations including the Leicester Colleges of Art and Technology and Leicester Polytechnic. Art, pharmacy, corsetry, footwear, physical sciences, and architecture were taught at the Schools and are still in evidence at DMU today, either as courses in their own right, or as integral components of more modern courses. The university has grown and evolved over the years, but it is still dedicated to providing inspirational teaching to students and it has a significant impact on the world around it.

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About Leicester School of Pharmacy

The Leicester School of Pharmacy is one of the UK’s most established pharmacy schools, with more than 100 years of teaching experience; renowned for academic expertise, professional development training and world-leading research. The school provides a diverse range of undergraduate, postgraduate and research opportunities that have been developed for traditional undergraduates as well as experienced practitioners looking to up-skill. Professional accreditations, strong links with industry and direct input from registered practitioners ensures The Leicester School of Pharmacy consistently produces graduates of the highest calibre. 

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About Quality by Design

The need to translate new molecules into high-value products is still a challenge for research centres across the globe. The Pharmaceutical Technology research group at DMU is leading in the area of continuous secondary manufacturing using QbD approach. We have been working closely with industry for over seven years to develop efficient and rapid methodologies to produce high quality medicines and developed innovative facilities and a broad range of supporters from the sector. Our expertise covers: Analytical Sciences, Drug Delivery, Materials Sciences, Manufacturing Processes including Continuous Manufacturing, Pharmaceutical Product Development and Process Analytical Technologies (PAT). This course is a unique integration of current knowledge on QbD from a group of leading experts in the pharmaceutical industry. It is an excellent training opportunity for those less familiar with QbD and provides more experienced students suggestions on how to enhance their QbD program.

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About Quality by Design

The need to translate new molecules into high-value products is still a challenge for research centres across the globe.  The Pharmaceutical Technology research group at DMU is leading in the area of continuous secondary manufacturing using QbD approach. We have been working closely with industry for over seven years to develop efficient and rapid methodologies to produce high quality medicines and developed innovative facilities and a broad range of supporters from the sector. Our expertise covers: Analytical Sciences, Drug Delivery, Materials Sciences, Manufacturing Processes including Continuous Manufacturing, Pharmaceutical Product Development and Process Analytical Technologies (PAT).  

This course is a unique integration of current knowledge on QbD from a group of leading experts in the pharmaceutical industry. It is an excellent training opportunity for those less familiar with QbD and provides more experienced students suggestions on how to enhance their QbD program.