Special Purpose Award in Pharmaceutical

& Medical Device Manufacturing (Level 8)

Course Content
The course consists of a series a scientific, technological, quality, improvement and
personal development modules designed and delivered by highly experienced
tutors.
Aseptic Processing and Utilities
Understand Heating Ventilation and Air Conditioning (HVAC). Review
Pharmaceutical Water Systems, Aseptic Processing, Cleanroom
Technology, Clean in place technology and validation of CIP.
Understand Isolation technologies, Sterilisation Methods and Sterility
testing.
Formulations Studies and Packaging.
Understand Physicochemical Properties, Powder Technology, Formulation
and Packaging.
Process Analytical Technology
Understand the new and exciting field of Process Analytical Technology the development and installation of technologies that can bring greater
control to pharmaceutical manufacturing processes.
Quality Risk Management
Understand the 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.
Lean / Six Sigma with Green Belt
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.
Corrective Action Preventative Action (CAPA) & Technical Report Writing
Understand how to determine the Root Cause of problems and develop
Creative Compliant Sustainable solutions. Understand how implement a
CAPA system within your organisation.
Understand the key success factors of Effective Report Writing.

Systems Validation
The module aims to provide the student with knowledge, documentation
requirements and hands-on experience in validating GMP critical systems.
Medical Device Technologies
Develop an understanding of the Medical Device industry.
Understand GMP and Regulatory requirements for Medical Devices.
Review Medical Devices in operation.
Understand Class I, II and III devices.
Pharmaceutical Process II
Gain an in-depth understanding of drug processing from lead compound
selection to finished product, focussing on key critical attributes such as
scale up, process optimisation, technology transfer, crystallisation powder
technology and control systems.
Business and Executive Coaching
Understand 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.