Certificate in Pharmaceutical & Medical Device Operations

Course Outline

The course duration is 9 months. Lectures will be delivered 2 evenings per week online. Students will also be required to attend 2 Saturdays a month on campus. (ECTS: 65 Credits)

Module 1: 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 a product.

Module 2: Facilities and Utilities Management

Understand the fundaments of Facilities / Utilities Management, Heating Ventilation and Air Conditioning (HVAC), Review Pharmaceutical Water Systems, Aseptic Processing, Cleanroom Technology, Clean In Place (CIP) technology and validation of CIP and Understand Isolation technologies, Sterilisation Methods and Sterility testing

Module 3: 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.

Module 4: Quality Assurance & 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 5: 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 6: Manufacturing Process Technology 

The steps normally used in a typical drug development process from discovery to market; the organisation of a  pharmaceutical plant and the functions of each department; the synthesis and purification of chemicals on a large scale; the equipment used in a bulk pharmaceutical plant and its operation; Waste treatment plant; record data during the manufacturing process.

Module 7: Preparation for Work for STEM

The importance of networking in today’s society; develop a personal carer plan; Write an appropriate CV that provides an outline of academic and employment experience; techniques and behaviours required to successfully succeed a job interview.

Module 8: Process Improvement 

Implementation of Lean and 6 Sigma process improvement tools such as; Value stream Mapping, 5S, OEE. Carrying our quality Investigation (Deviations) including use of Root Cause Analysis tools and implementing CAPA. Completion of lean 6 Sigma project.

Module 9: Learning to Learn

Personal Strengths and weaknesses as a learner, set specific learning goals and create a personal learning plan; Study effectively as an independent learner and work collaboratively as a member of a team; Manage time efficiently with regard to planning and organising learning tasks; Use critical thinking and analytical skills to solve a variety of problems; Write a research-based report and make an effective presentation; the importance of academic integrity and identify ways of avoiding plagiarism in academic work through appropriate referencing.