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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)
Structure and assessment
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).
- 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
Facilities and features
Health and Life Sciences facilities
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.
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 apply theory to practice in a safe environment. You will receive guidance and support from staff, to ensure that your practical ability in the clinical skills suites is accurate.
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.
Our Learning Zones and the 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
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.
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.