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Masters Degrees (Pharmaceutical Quality And Good Manufacturing Practice)

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This part-time course enables suitably-qualified pharmaceutical industry employees to. - acquire the necessary knowledge base to submit themselves for nomination as a Qualified Person (QP). Read more

Why this course?

This part-time course enables suitably-qualified pharmaceutical industry employees to:
- acquire the necessary knowledge base to submit themselves for nomination as a Qualified Person (QP)
- develop relevant academic knowledge and skills at postgraduate level
- develop research and investigative skills in the area of pharmaceutical quality and good manufacturing practice

The course is provided in a unique collaboration between:
- Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS)
- NSF Health Sciences (formerly known as NSF-DBA and David Begg Associates (DBA))

NSF-Health Sciences are leading experts in the pharmaceutical and medical devices industries offering training, consultancy and auditing services.

See the website https://www.strath.ac.uk/courses/postgraduatetaught/pharmaceuticalqualitygoodmanufacturingpractice/

You’ll study

You’re required to complete six of the NSF-DBA modules for consideration for the Postgraduate Certificate. For the Postgraduate Diploma you need to complete twelve modules.

Modules run over a 21-month period as a series of 13 one-week residential courses. You complete additional study before sitting examinations for the award of the Certificate or Diploma.

The Diploma can be converted to the MSc by completion of a research project which is normally undertaken at your workplace.

The course is by part-time study only.

Curriculum

The course is based on the syllabus in the European-approved 'Qualified Person' (QP) study guide as used in the pharmaceutical industry.

The course content includes all the diverse elements required to ensure that each batch of a medicinal product meets the quality requirements of the relevant product and manufacturer's licences. This includes:
- an understanding of the pharmacology and chemistry of the product's active and other ingredients
- a knowledge of how the product was manufactured
- how the product delivers the drug in the patient's body
- how the patient's body is expected to handle the drug by way of excretion and metabolism

You’re also made aware of the statutory framework which is applied in the control of the manufacture and distribution of medicinal products.

Facilities

The Strathclyde Institute of Pharmacy & Biomedical Sciences (SIPBS) offers an excellent environment for research and teaching. It’s located in a new building with several laboratories. All are fitted with modern equipment.

Teaching staff

Lecturers include:
- NSF-DBA staff
- personnel from the regulatory authorities and the pharmaceutical industry
- University of Strathclyde staff with expertise in pharmaceutical quality

Pre-Masters preparation course

The Pre-Masters Programme is a preparation course for international students (non EU/UK) who do not meet the entry requirements for a Masters degree at University of Strathclyde. The Pre-Masters programme provides progression to a number of degree options.

To find out more about the courses and opportunities on offer visit isc.strath.ac.uk or call today on +44 (0) 1273 339333 and discuss your education future. You can also complete the online application form. To ask a question please fill in the enquiry form and talk to one of our multi-lingual Student Enrolment Advisers today.

Learning & teaching

Each module consists of:
- lectures
- tutorials
- laboratories
- discussion groups
- relevant visits

The cohesion of the student group rapidly develops as all participants are generally working in some aspect of quality assurance in the pharmaceutical industry. As such, the informal aspects of each module can become an important part of the knowledge-gathering process.

Assessment

Modules are assessed individually. You’ll sit formal examinations. MSc students write and submit for examination a thesis based on their research project.

Careers

Gaining knowledge and skills will enhance your career progression in the pharmaceutical industry.

Find information on Scholarships here http://www.strath.ac.uk/search/scholarships/index.jsp

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Qualify as a pharmaceutical scientist on this new, Masters-level Pharmaceutical Manufacture and Quality Control course at Liverpool John Moores University. Read more
Qualify as a pharmaceutical scientist on this new, Masters-level Pharmaceutical Manufacture and Quality Control course at Liverpool John Moores University. Carry out novel research and gain hands-on laboratory experience.

•Complete this masters degree in one year (full time)
•Explore the drug development and quality control aspects of the pharmaceutical industry as you study to become a qualified pharmaceutical scientist
•Gain hands-on experience in relevant laboratory techniques with a 12 week research project
•Benefit from LJMU's £12 million laboratory investment
•Enjoy excellent graduate employment prospects

Enhance your subject knowledge and gain hands-on experience with this new Masters course, taught by tutors with personal industry experience and strong manufacturing connections.

Completing a PG Cert by the end of the first semester on this full time, year-long course, you will devote the next semester to Diploma level study and then undertake a 12 week laboratory project for the final part of your MSc.

There are opportunities for topic specialisation and the chance to undertake cutting edge research.

You will learn in a supportive, flexible academic environment, studying at the Byrom Street site, right in the heart of Liverpool city centre.

The School's laboratories are currently undergoing a £12 million upgrade. Here you’ll find chromatographic equipment and spectrometers, tableting and particle sizing equipment, computing laboratory and state-of-the-art molecular modelling software, electron spin resonance spectrometers and thermal analysis equipment, including dynamic differential scanning calorimetry plus chromatography, LC-MS and NMR instruments.
In terms of independent study support, the Avril Robarts Library, open 24/7 during semesters, is located just minutes away on Tithebarn Street.

Please see guidance below on core and option modules for further information on what you will study.

Research Methods
Gain the necessary core skills to effectively design, plan, perform and report scientific research.
Analytical Techniques, Structure and Function in Organic Molecules
Understand the application of analytical chemistry to pharmaceutical materials, and the effect of functional group chemistry on both the structure and consequent properties of relevant molecules.
Physicochemical Properties of Therapeutic Agents
Understand the physical and chemical properties of both small molecules and macromolecules and how these influence their in vitro and in vivo behaviour as active pharmaceutical ingredients.
Formulation and Drug Delivery
Understand the principles of pharmaceutical formulation and advanced drug delivery methods.
Product Development and Control
Understand and apply the principles of good manufacturing practice to the production and quality control of pharmaceutical products.
Research Project
Complete an independent, in-depth, 12 week scientific study related to the pharmaceutical sciences.

Further guidance on modules

The information listed in the section entitled ‘What you will study’ is an overview of the academic content of the programme that will take the form of either core or option modules. Modules are designated as core or option in accordance with professional body requirements and internal Academic Framework review, so may be subject to change. Students will be required to undertake modules that the University designates as core and will have a choice of designated option modules. Additionally, option modules may be offered subject to meeting minimum student numbers.

Please email if you require further guidance or clarification.

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The MEngSc/PG Dip in Pharmaceutical and Biopharmaceutical Engineering are part-time modular degrees which can be taken over 24 months (for award of a Postgraduate Diploma) to 60 months. Read more
The MEngSc/PG Dip in Pharmaceutical and Biopharmaceutical Engineering are part-time modular degrees which can be taken over 24 months (for award of a Postgraduate Diploma) to 60 months. You will have the opportunity to gain a formal qualification in areas of particular concern to the bio/pharmaceutical industry that you may not have benefited from before, including issues such as product containment, powder/particle technology, design of API and secondary production facilities, current Good Manufacturing Practice (cGMP), design of classified facilities, aseptic processing facility design and validation.

Visit the website: http://www.ucc.ie/en/ckr35/

Course Details

The aim of this course is to fill a need for the continuing professional development (CPD) and postgraduate education of engineers working in the pharmaceutical industry. This course covers issues of particular concern to the pharmaceutical industry such as product containment, powder/particle technology, design of API and secondary production facilities, current Good Manufacturing Practice (cGMP), design of classified facilities, aseptic processing facility design, validation, etc.

Format

The MEngSc course is in two parts. Part I (which constitutes the PG Diploma) involves taking 12 modules to the value of ECTS 60 credits. Taught modules are offered on a cyclical basis. Six modules are taken per annum over a two year period if you opt for full registration, although the course can be taken over a maximum of five years. Part II consists of a research thesis to the value of 30 credits. The choice of modules is subject to the approval of the course coordinator.

Part I

Students take 60 credits from the following:

Offered in 2015/16
PE6010 Pharmaceutical Engineering (5 credits)
PE6011 Biopharmaceutical Engineering (5 credits)
PE6012 Pharmaceutical Process Equipment; Materials and Mechanical Design (5 credits)
PE6013 Powder and Particle Technology and Unit Operations (5 credits)
PE6014 Chemical Kinetics, Reactor Design and Bioreactor Engineering (5 credits)
PE6015Environmental Engineering in the Pharmaceutical Sector (5 credits)
PE6023 Pharmaceutical and Biopharmaceutical Utilities (5 credits)
PE6025 Advanced Health & Safety Management (5 credits)

Offered in 2016/17
PE6016 Pharmaceutical Industry; Manufacturing and Optimisation (5 credits)
PE6017 Pharmaceutical Plant Design and Project Management (5 credits)
PE6018 Pharmaceutical Process Validation and Quality (5 credits)
PE6019 Process Analytical Technology (5 credits)
PE6022Aseptic Manufacturing Design (5 credits)
PF6302 Introduction to Pharmaceutics: Formulation Science (5 credits)
PE6024 Advanced Process Design & Safety Engineering (5 credits)
PE6025 Advanced Health & Safety Management (5 credits)

Part II (MEngSc only):

PE6021 Dissertation in Pharmaceutical and Biopharmaceutical Engineering (30 credits)

These are subject to change. For full course information see programme website - http://www.ucc.ie/en/processeng/postgrads/taughtmasters/mengsc//

Further details on the content and modules are available on the Postgraduate College Calendar - http://www.ucc.ie/calendar/postgraduate/Masters/engineering/page08.html

Assessment

Assessment is by continuous assessment and end of period exams.

Careers

The course offers graduates working in the pharmaceutical industry the opportunity to further develop your skills set and employability across a wider range of roles in the industry through enhanced continuing professional development.

Through the opportunities provided by participation on the programme, you are provided with opportunities to enable greater cohesion and understanding among inter-and multi-disciplinary teams while earning a formal qualification in engineering.

How to apply: http://www.ucc.ie/en/study/postgrad/how/

Funding and Scholarships

Information regarding funding and available scholarships can be found here: https://www.ucc.ie/en/cblgradschool/current/fundingandfinance/fundingscholarships/

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The PG Dip in Pharmaceutical and Biopharmaceutical Engineering is a part-time modular degree which can be taken over 24 months to 60 months. Read more
The PG Dip in Pharmaceutical and Biopharmaceutical Engineering is a part-time modular degree which can be taken over 24 months to 60 months. You will have the opportunity to gain a formal qualification in areas of particular concern to the bio/pharmaceutical industry that you may not have benefited from before, including issues such as product containment, powder/particle technology, design of API and secondary production facilities, current Good Manufacturing Practice (cGMP), design of classified facilities, aseptic processing facility design and validation.

Visit the website: http://www.ucc.ie/en/ckp08/

Course Details

Many graduates working in the pharmaceutical industries with a scientific background find themselves working in areas which increasingly overlap with engineers and engineering. Many would like to develop an engineering-based understanding of processes and production in a formal manner. This course offers you the opportunity to do this, developing your skills set and employability across a wider range of roles.

The course also presents the pharmaceutical and biopharmaceutical industry with an opportunity to enable greater cohesion and understanding among inter- and multi-disciplinary teams as graduates with science backgrounds receive a formal qualification in engineering.

Format

The PGDip involves taking 12 modules to the value of ECTS 60 credits. Taught modules are offered on a cyclical basis. Six modules are taken per annum over a two year period if you opt for full registration, although the course can be taken over a maximum of five years. The choice of modules is subject to the approval of the course coordinator. Candidates who achieve an average of 50% in all taught modules may apply for entry to the MEngSc to complete a thesis.

Part I

Students take 60 credits from the following:

Offered in 2015/16

PE6010 Pharmaceutical Engineering (5 credits)
PE6011 Biopharmaceutical Engineering (5 credits)
PE6012 Pharmaceutical Process Equipment, Materials and Mechanical Design (5 credits)
PE6013 Powder & Particle Technology and Unit Operations (5 credits)
PE6014 Chemical Kinetics, Reactor Design and Bioreactor Engineering (5 credits)
PE6015 Environmental Engineering in the Pharmaceutical Sector (5 credits)
PE6023 Pharmaceutical and Biopharmaceutical Utilities (5 credits)
PE6025 Advanced Health & Safety Management (5 credits)

Offered in 2016/17

PE6016 Pharmaceutical Industry, Manufacturing and Optimisation (5 credits)
PE6017 Pharmaceutical Plant Design and Project Management (5 credits)
PE6018 Pharmaceutical Process Validation and Quality (5 credits)
PE6019 Process Analytical Technology (5 credits)
PE6022 Aseptic Manufacturing Design (5 credits)
PF6302 Introduction to Pharmaceutics: Formulation Science (5 credits)
PE6024 Advanced Process Design & Safety Engineering (5 credits)
PE6025 Advanced Health & Safety Management (5 credits)

Part II (MEngSc only)

PE6021 Dissertation in Pharmaceutical and Biopharmaceutical Engineering (30 credits)

These are subject to change. For full course information see programme website - http://www.ucc.ie/en/processeng/postgrads/taughtmasters/mengsc//

Further details on the content and modules are available on the Postgraduate College Calendar - http://www.ucc.ie/calendar/postgraduate/Masters/engineering/page08.html

Placement and study abroad

Students will study at a UCC partner university in China and take the equivalent of 60 credits there in the Third Year.

Assessment

Assessment is by continuous assessment and end of period exams.

Careers

The course offers graduates working in the pharmaceutical industry the opportunity to further develop your skills set and employability across a wider range of roles in the industry through enhanced continuing professional development.

Through the opportunities provided by participation on the programme, you are provided with opportunities to enable greater cohesion and understanding among inter-and multi-disciplinary teams while earning a formal qualification in engineering.

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Quality by Design (QbD) is based on the application of product and process sciences, from early-to-late stages of the product development cycle, to provide accelerated regulatory submission pathways for new drug applications. Read more
Quality by Design (QbD) is based on the application of product and process sciences, from early-to-late stages of the product development cycle, to provide accelerated regulatory submission pathways for new drug applications.

•This is the first MSc dedicated to the new QbD approach to pharmaceutical process and product development
•QbD instils quality into the product while it is being developed and manufactured rather than waiting for post-production testing
•This forms 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 Committee on Harmonization (ICH)
•Benefit from investment in new, dedicated good manufacturing practice laboratories, links to the pharmaceutical industry and involvement of industrial practitioners in our course design and delivery

The course contains areas of core knowledge and skills with an emphasis on application of ‘Quality by Design’ principles and continuous improvement activities to the development and manufacture of pharmaceutical products. The course has been structured to ensure you have a coherent and balanced programme of study in the following areas:

• Principles and Practices of Quality by Design
• Product Design: Pre-formulation and Formulation
• Analytical Techniques in Materials Science
• Process Design, Control and Manufacturing
• Advances in Drug Delivery
• Biopharmaceuticals
• Process Analytical Technology and Chemometrics
• Experimental Design and Research Methods

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The MSc in Biotechnology is a one-year course designed to provide you with the theoretical and practical skills for employment in the industries of biomedical research, biopharmaceuticals, agrochemicals and biotechnology. Read more
The MSc in Biotechnology is a one-year course designed to provide you with the theoretical and practical skills for employment in the industries of biomedical research, biopharmaceuticals, agrochemicals and biotechnology. The course curriculum consists of six months of lectures, laboratory practical sessions, career service workshops, industry-based seminars and a six-month research project. The curriculum has been developed with input from staff in local biotechnology and biopharmaceutical industries, to provide you with the necessary skills required by employers. Students have the choice to complete the six-month research project in a national or international industry or university environment.

Visit the website: http://www.ucc.ie/en/ckr01/

Course Details

This is the most established MSc in Biotechnology course in Ireland and is the most popular MSc course in UCC. The international success of this course is attributed to the industry-led curriculum offered to students and the opportunity to complete a six-month placement in industry or an academic research lab. The global recognition of the course is also evident from our international alumni and receipt of several industry-sponsored scholarships available to students entering and on completion of the course.

The course will:

- introduce you to the theory and practice of bioanalytical chemistry?
- introduce you to molecular biotechnology, eukaryotic-, prokaryotic- and plant-biotechnologies, recombinant DNA technologies and their - application in the biotechnology and biopharmaceutical industries
- introduce you to the principles of process and biochemical engineering?
- introduce you to the role of process validation and quality assurance in the pharmaceutical industry, and give you an awareness of the - - latest trends in good manufacturing, laboratory and validation practices
- introduce you to the principles of food and industrial microbiology
- provide you with the opportunity to conduct and complete a body of independent research in a biotechnology-related area and present your research findings in a minor dissertation.

Format

The curriculum consists of approximately 250 contact hours over two academic terms (October to December and January to March), consisting of eight course modules, set practical sessions, career service workshops and an industry lecture series.

During the third academic term (April to September), students complete a six-month research project on a topic related to biotechnology, biopharmaceutical or biomedical research. Industry-based projects in these areas are managed by a dedicated placement officer who facilitates career workshops during which you prepare for and are interviewed by staff from companies interested in hosting students. For students interested in a career in biomedical research or PhD, projects are offered in a broad range of research areas utilising modern research techniques. All research projects are undertaken in consultation with an academic supervisor and examiner.

The MSc in Biotechnology degree course consists of eight course modules, set practical sessions, career service workshops, an industry lecture series and a six-month research project.

Students study the following eight modules and complete a research project:

- Advanced Molecular Microbial Biotechnology
- Biopharmaceuticals: formulation design, secondary processing and regulatory compliance
- Bioprocess Engineering
- Cell and Molecular Biology
- Functional Foods for Health
- Genetic Engineering
- Modern Methods in Analytical Chemistry
- Plant Genetic Engineering

Research Project and Industry Placement

You will be required to complete a six-month research project based on your individual research and development in a selected field of modern science. You carry out your research in UCC’s laboratories or at an approved academic or industrial partner.

When you complete your research dissertation in an industrial setting, it provides the company with an opportunity to assess your skills and abilities and to screen potential future full-time employees.

Students who secure employment upon graduation fit into the organisation and contribute productively much sooner that other graduates. For students with an interest in biomedical research and future careers as PhD researchers, research projects are offered across a broad range of topics including but not limited to; cancer biology, neuroscience, immunology, microbiology and plant biotechnology.

Further details on the content and modules are available on the Postgraduate College Calendar - http://www.ucc.ie/calendar/postgraduate/Masters/science/page05.html#4%20

Assessment

The MSc in Biotechnology is awarded after passing written examinations across taught course units, the continuous assessment of practical work and completion of a six-month research project, which has to be written up in the form of a dissertation and approved by an external examiner. All students must complete written examinations (typically held over a two week period in March) and submit a research project. Full details and regulations governing examinations for each course will be contained in the Marks and Standards 2013 Book and for each module in the Book of Modules, 2015/2016 - http://www.ucc.ie/modules/

Careers

The course is suitable for students wishing to extend their specific undergraduate degree knowledge in biotechnology, and for those wishing to bridge their undergraduate degree and gain more specialised knowledge and training in biotechnology. The course allows you to follow a number of career pathways. Each year, over 70 per cent of our students gain employment while approximately 20 per cent of graduates progress to international PhD opportunities.

How to apply: http://www.ucc.ie/en/study/postgrad/how/

Funding and Scholarships

Information regarding funding and available scholarships can be found here: https://www.ucc.ie/en/cblgradschool/current/fundingandfinance/fundingscholarships/

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