Masters (MSc) / Postgraduate Diploma in Analytical Science ...€¦ · latest developments in advanced analytical techniques and quality management. Part-time Postgraduate Masters

Level 9

The MSc / PG Diploma in Analytical Science with Quality Management programmes are two-year part-time taught postgraduate programmes that were developed to address scientific skills gaps within the pharmaceutical, biopharmaceutical and healthcare sectors. The programmes are aimed at those already working in these industries who wish to upskill in the latest developments in advanced analytical techniques and quality management.

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Masters (MSc) / Postgraduate Diploma in Analytical Science with Quality Management

www.wit.ie/wd520 www.pac.ie

Programme StructureStudents of the MSc/PG Diploma study three modules in each academic year. Each of these 10 credit modules can also be taken as a stand-alone Certificate award.

PG Diploma in Analytical Science with Quality Management WD519

Advanced Chromatographic Techniques 10 credits

Advanced Spectroscopic Techniques 10 credits

Advanced Materials Characterisation 10 credits

Strategic Quality Management 10 credits

Statistics and Data Analysis 10 credits

Choose one elective:

• International Regulatory Affairs • Biopharmaceutical Analysis and Cell Culture

• Advanced Drug Formulation Science • Food Safety and Analytical Microbiology

10 credits

MSc in Analytical Science with Quality Management WD520

Research Dissertation (MSc) 30 credits

Programme OutlineThis programme aims to produce graduates with the necessary knowledge, skills and expertise in advanced analytical techniques, focusing in particular on separation techniques, detection techniques and materials characterisation. The programme also aims to produce graduates with expert knowledge of advanced quality methodologies. The programme places a strong emphasis on the professional development of the graduate, to enable them greater flexibility in the development of their own career options over the span of their career. Specifically the programme aims are to:

n Graduate individuals who have an advanced knowledge of the disciplines of analytical science and quality management.

n Graduate students who can lead their company’s quality programmes.

n Enable graduates to assess the potential of and implement new analytical technology within an industrial environment.

n Graduate students with advanced research skills.

MSc / PG Diploma in Analytical Science with Quality Management


Certificate in Advanced Chromatographic Techniques WD575

Website: www.wit.ie/wd575 Level: 9 Credits: 10 ECTS

This course was developed to provide the student with an advanced understanding of the theory, practices and

instrumentation associated with chromatographic separation techniques. The focus is primarily on High Performance Liquid

Chromatography (HPLC) and Gas Chromatography (GC), Ion Chromatography IC) and reverse-phase bioseparations. The

interfacing of hyphenated techniques involving Mass Spectrometry (MS), such as LC-MS and GC-MS, is also covered.

The student will be exposed to state-of-the-art developments in associated instrumentation, and learn to competently operate,

calibrate and qualify associated laboratory instrumentation. The student will be exposed to the application of advanced

chromatographic techniques in a wide range of industrial environments focusing mainly, but not exclusively, on applications in

the pharmaceutical and biopharmaceutical industries. This will enable them to select an appropriate separation technique for

a given analysis in a range of industrial environments. The student will also learn to resolve sample preparation and method

development issues for the chromatographic separation of samples in complex matrices.

Certificate in Advanced Spectroscopic Techniques WD576



instrumentation associated with spectroscopic detection techniques. A broad range of molecular and atomic spectroscopic

techniques are covered. The molecular spectroscopy techniques include UV-Vis Spectroscopy, Fluorescence Spectroscopy,

Infrared (IR) Spectroscopy, Raman Spectroscopy, Nuclear Magnetic Resonance (NMR) Spectroscopy and Mass

Spectrometry (MS). The atomic spectroscopy techniques include Atomic Absorbance Spectroscopy (AAS) and Inductively

Coupled Plasma Optical Emission Spectroscopy (ICP-OES). The focus of the module is on state-of-the-art developments in the

practices and instrumentation associated with these techniques.

The student will be exposed to the application of advanced spectroscopic techniques in a wide range of environments

focusing mainly, but not exclusively, on applications in the pharmaceutical and biopharmaceutical industries. The student

will also learn to resolve sample preparation issues relating to the use of advanced spectroscopic techniques, and to resolve

method development issues concerned with mass spectrometry and related hyphenation techniques. The student will also

learn to employ appropriate advanced data analysing, synthesising and summarising skills in spectroscopic techniques, in

order to enable the spectroscopic identification of samples in complex matrices.

Certificate in Advanced Materials Characterisation WD577


This course was developed to provide the student with an overview of the current technologies used for the characterisation

of materials in industrial applications. The focus is mainly, but not exclusively, on the pharmaceutical and biopharmaceutical

industries, from raw materials and product characterisation, to trace analysis and impurity determinations. The principles

and instrumentation used in a range of techniques employed for surface analysis, polymorphism, trace analysis and polymer

characterisations will be studied, focusing on their uses, sample requirements and limitations.

Students will get hands-on experience of the following materials characterisation techniques in laboratory practicals:

• Differential Scanning Calorimetry (DSC)

• Thermogravimetric Analysis (TGA)

• Dynamic Vapour Sorption (DVS)

• Particle Size Analysis (laser diffraction)

• X-ray Diffraction (XRD)

• Rheology and Powder Rheometry

• Surface Area Analysis and Pore Size Measurements (Gas Sorption)

• Scanning Electron Microscopy (SEM)

• Atomic Force Microscopy (AFM)

• Solid-state Nuclear Magnetic Resonance (SS-NMR) spectroscopy


Certificate in Strategic Quality Management WD580



implementation issues associated with advanced quality methodologies such as Leadership, Six Sigma and Lean

Manufacturing. It will provide the student with the skills necessary to evaluate how lean, Six Sigma and risk management

principles can be used to guide lean implementation, and to identify the key factors for effective motivation of staff applying

these lean tools and techniques. The course will also develop the student’s competence in a range of technical and

management quality tools, and demonstrate how these can be applied in an industrial environment.

Competitive advantage, project management and managing change are key components of applying strategic quality

management principles in an industrial setting, and these will be covered in detail. Critical thinking, problem solving and

decision making will be key components of this learning. The student will also learn to critically evaluate the importance and

practices of analytical method transfer and equipment validation activities, including automated and computer systems, and

how to develop a systematic approach to validation experimentation. This will include evaluation of the effect that routine

laboratory operations have on the quality of the final product.

Certificate in Statistics and Data Analysis WD581


This course focuses on the application of modern data analysis techniques in the context of analytical method development.

The course enables the student to apply statistical analysis processes to data sets, and to interpret the results in order to quantify

data quality and compare data sets. Dedicated statistical software packages will be used for the delivery of this programme,

features of which will enable the student to perform a comprehensive analysis and assessment of data quality. The student will

learn to critically analyse analytical data using appropriate descriptive statistics tests, and to critically assess data sets based

on applied inter-comparison significance tests. These data sets will deal with real world applications from the pharmaceutical,

biopharmaceutical and food industries.

The student will also develop competence in a range of process control tools and minimisation strategies, and will learn to justify

their usefulness to control a process. In addition, the student will learn to critically evaluate sampling plans and perform statistical

analysis of quality in product batches. Continuous improvement and data-driven decisions will also be emphasised throughout

the course.


Certificate in International Regulatory Affairs WD583


This course will provide the student with an understanding of the processes for providing regulatory support to the facility

ensuring compliance with ICH, EMA and FDA legislation. The course will also describe the mechanisms for bringing a new

medicinal entity for human use to market, to obtaining marketing authorisations, to maintaining the drug authorisation process

through the variations process, and post marketing surveillance strategies to ensure that market vigilance is maintained after

the medicinal product has been launched and becomes a commercial entity.

This course will also provide the student with an advanced understanding of the procedures involved in the regulation of

pharmaceutical products in the EU, US and other markets. The structure and role of US, European and other regulatory

authorities will be studied. Harmonisation of standards in the pharmaceutical industry and the various licensing routes for drug

products in the EU will also be objectives of the course. The learner will be exposed to the interface between regulatory affairs

and operations. Pharmacovigilance and the pharmaceutical inspection convention will also be emphasised throughout the

course of the programme.

Certificate in Advanced Drug Formulation Science WD605


This course was developed to provide the student with a clear understanding of the pharmaceutical development pathway,

from pre-clinical to clinical and pharmaceutical development. The aim of the course is to give the student an advanced

understanding of formulation science, technology and the properties of pharmaceutical drug products, in order to assess

the potential of and implement new formulation methodologies in an industrial environment. The course will cover the

physicochemical basis of pre-formulation studies, and the student will learn to evaluate how the physicochemical properties

of drug molecules and excipients influence the choice of drug dosage form, and subsequent formulation and manufacturing

procedures.

The course also deals with the development of dosage forms for achieving acceptable bioavailability and required efficacy.

The student will gain a detailed understanding of specific drug formulation methodologies, such as spray drying for poorly

soluble drugs, aerosol drug formulation and oral liquid/suspension formulation, and will learn method development strategies

for these. The student will also be exposed to the area of sterilisation requirements for parenteral drugs, as well as stability

involving lyophilisation for protein stabilisation.


Certificate in Biopharmaceutical Analysis and Cell Culture WD594


This course was developed to provide the student with an in-depth knowledge of and the skills used in biopharmaceutical

production, analysis and cell culture-related topics. Students will be exposed to a set of technologies that provide state-of–the-

art tools for genomics, proteomics, screening and the analysis of recombinant proteins and monoclonal antibodies. In addition,

an overview of emerging cell and gene therapies, including genome editing, will be provided. The course will also introduce

different techniques to analyse biopharmaceuticals, including immunoassays and next-generation bioarrays and bioassays. The

practical aspects of the course will cover up/downstream biopharmaceutical purification and analysis techniques, and essential

cell culture skills.

The course will also train the student to critically evaluate approaches for method development and quality monitoring in

biopharmaceutical production, and to identify future trends in the biopharmaceutical industry. In summary, this course will furnish

the student with a competency required to undertake mammalian cell culture projects, the ability to select the best techniques

needed to analyse different biopharmaceuticals, and a qualification that is particularly relevant to the rapidly growing

biopharmaceutical sector.

Certificate in Food Safety and Analytical Microbiology WD585


This course will provide the student with an advanced understanding of the theory, practices and implementation issues

associated with food industry safety management, while incorporating a comprehensive overview of the theoretical background,

methodologies and practical skills in modern methods of analysis of foods for microbial contaminants. The student will be

exposed to aspects of working in an environment that operates under strict guidelines for production and quality outputs.

The aims of the course are to produce graduates with an in-depth knowledge of food industry safety management, as well as

modern methods of microbiological analysis of foods and food production premises. The student will acquire the tools and skills

in modern methods and the technology associated with the analysis of foods and production facilities for microbial contaminants.

The course will also enable students to critically appraise the scientific literature and identify future trends in the areas of food

safety and analytical microbiology.


Student Testimonials

‘I work as an Instrument Validation Specialist with Merck Sharpe and Dohme, Ireland. I have recently moved to MSD Biotech (Biopharmacetical site). With this move in mind I’m very pleased that I took the biopharmaceutical elective module during the Master’s program at WIT, as it gave me a greater understanding of this side of the business and has given me a strong, well-rounded platform moving into my new role.

Additionally, the advanced spectroscopic and chromatographic techniques modules built upon undergraduate study and industry experience and I thoroughly enjoyed the practical lab element of method development. Throughout the two years of the program the lecturers/staff at WIT were always very helpful and approachable, which made a big difference.’ Martin Delahunty

‘During my time studying for the MSc in Analytical Science with Quality Management I found the course material to be very interesting and varied. I was able to take my learnings back to industry and the knowledge I gained has been a great benefi t to my workplace. It has enabled me to troubleshoot and solve analytical issues and also to become more confi dent in my work.

As a result I have been given more responsibility and been designated to more development projects. I found the teaching staff very helpful and supportive and, combined with the course lectures and practicals, made my time studying at WIT very enjoyable.’ Aoife Drennan

‘A lot of the subjects I studied and a lot of the topics that were covered by the course co-ordinators were very relevant to what I do. The degree I completed was years ago so after completing the masters, a lot of my techniques and instrumentation knowledge has been updated and advanced. Doing a masters is also important for the role I am currently in as it improved my abilities as a chemist. All these reasons combined with WIT’s high standards helped make my mind up.

The relevance of the topics covered in the course and the helpfulness of the lecturers was just incredible. Overall, I had a great experience and I felt it really enhanced my skills in the workplace, which was the outcome I was hoping for.’ Joe Williams

Award n To achieve the Postgraduate Diploma award students must

accumulate 60 credits by completing six 10 credit modules.

n To achieve the MSc award students must additionally complete a 30 credit research dissertation, which is carried out in the student’s workplace.

n Students can apply for an exit award of an individual Level 9

Certificate for each module they successfully complete.

n Successful completion of one or more stand-alone Certificate programmes can also be used as credit towards the MSc/PG Diploma award.

Entry RequirementsApplicants for entry to these programmes should:

n Applicants should hold a bachelors degree at honours level minimum 2.2 (Level 8) in an appropriate subject area or equivalent qualification.

n Applicants should also have a minimum of two years relevant industrial experience.

n For applicants whose primary language is not English, evidence of competency in English must be submitted. Please see our website for more details at www.wit.ie/englishrequirements

FeesFor information on fees please visit our website at www.wit.ie/pgfees

ApplicationsApplications for these programmes are made online by going to www.pac.ie

For more detailed information please visit our website at www.wit.ie/wd520

ContactsProgramme Leaders:

Dr. Kathleen Grennan T: 051 302047 E: [email protected]

Dr. Mike Kinsella T: 051 834044 E: [email protected]

Admissions queries contact:

Graduate Admissions, Office of the Registrar, Waterford Institute of Technology

T: 051 302670 E: [email protected]

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Programme deliveryThe programmes are delivered through a blend of lectures, tutorials, laboratory-based practicals and projects. Students will typically be required to attend WIT for no more than 8 days per module, amounting to a maximum of 24 days per academic year. Some material is delivered in an e-learning capacity to facilitate distance learning.


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Masters (MSc) / Postgraduate Diploma in Analytical Science ...€¦ · latest developments in advanced analytical techniques and quality management. Part-time Postgraduate Masters