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Higher Diploma in Science in Quality Systems Validation with Data Analytics

HDip in Sc
Programme Code: CR_SQSDA_8
Mode of Delivery:Full Time, Part Time, ACCS, Partially Online
No. of Semesters:2
NFQ Level:8
Embedded Award:No
Programme Credits:60
programmeReviewDate:September 2023
Field of Study:Chemistry

Programme Outcomes

Upon successful completion of this programme the graduate will be able to demonstrate... :

PO1 Knowledge - Breadth
  (a) An understanding of the theory and concepts relating to the discipline areas of Quality Systems, Statistical Quality Control and Data Validation, Analytics & Integrity.
PO2 Knowledge - Kind
  (a) A detailed knowledge and understanding of the terminology, defining concepts and applications of the theory underlying Validation, Statistical Quality Control, Data Analytics and Data Integrity, with a critical understanding of the appropriate contexts for their use; relate current issues in Quality Control, Data Validation and Data Integrity to applications in industry, including current limits of theoretical and applied knowledge.
PO3 Skill - Range
  (a) Mastery of relevant skills and tools associated with IT-based Validation systems (e.g. Process, Analytical and Clean-room), Regulatory Affairs and Data Integrity and the ability to use these skills to solve complex problems involving analytical data sets; interpret and apply appropriate and reliably sourced technical/scientific literature and other information sources to assist problem solving; work independently within defined time and resource boundaries; communicate technical information in a variety of forms to specialist and non-specialist audiences.
PO4 Skill - Selectivity
  (a) An ability to formulate and test hypotheses; design experiments; appreciate current limits of knowledge in the Quality Control and Data Validation & Integrity fields and respond appropriately; to think independently and make effective decisions; contribute fully to the day-to-day operations of the Quality Control and Data Validation/Integrity in a highly regulated advanced manufacturing industry setting.
PO5 Competence - Context
  (a) The use of advanced skills to conduct research, or advanced technical or professional activity, accepting accountability for all related decision making; transfer and apply diagnostic and creative skills in a range of contexts. Apply data analysis skills and technologies in a range of contexts in order to critically interpret existing knowledge and apply in new situations; make and report appropriate decisions in a responsible and ethical manner. Specifically, to demonstrate competence in computer-based IT skills, the use of software packages for text and data processing (e.g. Empower, Minitab, SPSS, DeltaV, etc) and in the statistical interpretation of scientific data and industrial processes.
PO6 Competence - Role
  (a) The ability to act effectively under guidance in a peer relationship with qualified practitioners; participate constructively in a complex interdisciplinary team environment; plan for effective project implementation; reflect on own practices. Specifically, learners should demonstrate the ability to fit into QC/QA/Validation roles requiring data analytics skills in advanced regulated manufacturing industries such as, biopharmachemical, food & beverage, water supply and analysis, petrochemical and medical device sectors.
PO7 Competence - Learning to Learn
  (a) The ability to act in variable and unfamiliar learning contexts; ability to identify learning needs and undertake continuous learning in the Quality Control & Data validation fields; assimilate and apply new learning. Specifically, learn to analyse and trouble shoot variations from planning and use data analytics in conjunction with process control and optimsation (e.g. Lean Sigma) techniques to problem solve.
PO8 Competence - Insight
  (a) The ability to express a comprehensive, internalised, personal world view, manifesting solidarity and empathy with others. Develop an understanding of the wider social, political, business and economic contexts of product development, supply and validation for market, specifically high value and potentially life saving highly regulated products (e.g. Pharmaceuticals) including an appreciation of the philosophical and ethical issues involved.

Semester Schedules

Stage 1 / Semester 1

Module Code Module Title
CHEM8011 Quality Systems, LIMS and SQC
CHEM8012 Validation of Quality Systems
CHEM8013 Regulatory Affairs & Auditing
CMOD8001 Prof. Development & Comm.
CHEM8014 Management and Leadership
STAT8015 Data Analytics & Chemometrics

Stage 1 / Semester 2

Module Code Module Title
CHEM8015 Experimental Ind. Project
CHEM8016 Regulatory Industry Placement

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