Course Outline
Lectures are delivered 2 evenings per week Online and 2 Saturdays per month in Dublin or Cork. Labs are held in Technological University Dublin - Tallaght Campus with times and dates subject to scheduling.
Module 1: Aseptic Processing and Utilities
Heating Ventilation and Air Conditioning (HVAC). Review Pharmaceutical Water Systems, Aseptic Processing, Cleanroom Technology, Clean In Place technology and validation of CIP. Isolation technologies, Sterilisation Methods and Sterility testing.
Module 2: Formulations Studies and Packaging.
Physicochemical Properties, Powder Technology, Formulation and Packaging.
Module 3: Process Analytical Technology
The new and exciting field of Process Analytical Technology - the development and installation of technologies that can bring greater control to pharmaceutical manufacturing processes.
Module 4: Quality Risk Management
A new area of managing risk within the pharmaceutical industry. This approach is heralded by the FDA and Industry as an opportunity for manufacturers to identify and focus on the high-risk aspects of their business.
Module 5: Lean / Six Sigma
Lean Thinking focuses on eliminating non-value added activities. Six Sigma is a methodology to reduce the variability thereby providing a more robust process. The combination of both techniques delivers processes which are very reliable and produce little
waste, develop the skills to understand and achieve significant improvements.
Module 6: Corrective Action Preventative Action (CAPA) & Technical Report Writing
How to determine the Root Cause of problems and develop Creative Compliant Sustainable solutions. Understand how to implement a CAPA system within your organisation, the key success factors of Effective Report Writing.
Module 7: Systems Validation
The module aims to provide the student with knowledge, documentation requirements and hands-on experience in validating GMP critical systems.
Module 8: Medical Device Technologies
Develop an understanding of the Medical Device industry, GMP and Regulatory requirements for Medical Devices, review Medical Devices in operation. , Understand Class I, II and III devices.
Module 9: Pharmaceutical Process I
The module aims to provide the student with knowledge of the equipment and technology required for the manufacture of pharmaceutical products.
Module 10: Business and Executive Coaching
How to deal effectively with change, optimize your CV and excel at interviews, develop your communication & presentation skills, become an effective listener and increase your confidence.