Course Outline
This part-time course runs over four semesters. Lectures take place two evenings per week both in a classroom environment or online if more convenient for those with a busy lifestyle. The practical modules are delivered in our pilot facilities two
Saturdays per month. (ECTS: 120 Credits)
Semester One
Module 1: Fundamentals of Science for Process Operators
Calculation and conversion, functional groups and molecular structures, physical and chemical measurements, routs of drug absorption, mechanisms of metabolism and excretion.
Module 2: Learning to Learn at 3rd Level
Personal strength and weaknesses, time management, critical thinking, plagiarism, working independently and in a team.
Module 3: Manufacturing Process Technology
Structure of the food industry in Ireland, steps involved in the manufacturing of commercial food items, operations and processes involved in food production, equipment.
Module 4: Utilities and Facilities Management
The key systems and process which fall under the framework of facility and utility systems; the components and operation of utility system generation and distribution; maintenance, reporting and management processes; the regulatory requirements applying to these systems; the commercial aspects in the management of these systems
Semester Two
Module 5: Process Improvement - Lean Six Sigma
Lean Thinking, Six Sigma, Map Process, data collection, validation and analysis of root cause, CAPA
Module 6: Food Regulatory Affairs
Quality Management System, EU regulatory for industrial and retailer standards in the food industry, QC testing, Food Hygiene Standards, non-conformance.
Module 7: Medical Device Operations
Medical interventions and treatments provided to patients; operation of a medical device manufacturing facility; Good Manufacturing Practices and Quality Systems in Medical Device manufacturing; manufacturing processes and standards used during the processing of medical device products
Module 8: Food Microbiology
Microbiology in the Food industry, microbiological risks in food processing, contamination control system and procedures, hygiene regime, decontamination of work areas.
Semester Three
Module 9: Applied Mathematics for Process Operators
Calculation of concentration and dilutions, accuracy and precision, probability, statistical data
Module 10: Quality Assurance and GMP
Regulatory requirements for pharmaceutical manufacturing; documented procedures, Standard Operating Procedures, Batch Manufacturing Records; the role of audits, corrective actions and change control; the role and function of Quality Control and Quality Assurance; the role of the employee in delivering products; Interpretation and use of quality specifications.
Module 11: Occupational Safety and Environmental Safety
Responsibilities and roles under international legal frameworks, safety statements and step in the preparation, types of hazards, waste materials and contaminants.
Module 12: HACCP Quality Systems in Food Manufacturing
Principle of HACCP and GMP in the food industry, audits and regulatory requirements.
Semester 4
Module 13: Preparation for Work
Personal career development, networking, CV preparation and interview skills.
Module 14: Food Manufacturing and Processing
Structure of the food industry in Ireland, steps involved in the manufacturing of commercial food items, operations and processes involved in food production, equipment.
Module 15: Pharmaceutical Science
Pharmaceutical dosage forms, drug product formulation and their chemical function, unit operations in pharmaceutical manufacturing processes, prepare granulates, formulate tablets, and analyse final formulations; types of packaging, closure systems and tamper evident seals and labels used for products
Module 16: Quality Control and GMP
The agencies which regulate healthcare manufacturing; management of regulatory documentation; the principles of validation; the QC testing pathway; QC specifications of ingredients, components and products.