8/10/2019 Special Purpose Award in Pharmaceutical

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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, CleanroomTechnology, Clean in place technology and validation of CIP.

Understand Isolation technologies, Sterilisation Methods and Sterilitytesting.

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 greatercontrol to pharmaceutical manufacturing processes.

Quality Risk Management

Understand the new area of managing risk within the pharmaceuticalindustry. This approach is heralded by the FDA and Industry as anopportunity for manufacturers to identify and focus on the high risk aspectsof their business.

Lean / Six Sigma with Green Belt

Lean Thinking focuses on eliminating non-value added activities. Six Sigmais a methodology to reduce the variability thereby providing a more robustprocess. The combination of both techniques delivers processes which arevery 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 aCAPA system within your organisation.

Understand the key success factors of Effective Report Writing.

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8/10/2019 Special Purpose Award in Pharmaceutical

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Systems Validation

The module aims to provide the student with knowledge, documentationrequirements 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 compoundselection to finished product, focussing on key critical attributes such asscale up, process optimisation, technology transfer, crystallisation powdertechnology 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.