GMP for Engineers - What you need to know
Course aim
This CPD course, developed in partnership with McGee Pharma International, has been designed to provide an understanding of the GMP requirements for engineers and an overview of the current ‘hot topics’ within the pharmaceutical industry. This course will provide delegates with an in-depth knowledge of current engineering practices and technologies as they are applied within the pharmaceutical industries.
Overview
Ireland is home to manufacturing sites from most of the world’s leading pharmaceutical companies. Manufacturing of their products must take place according strict regulatory guidelines which include GMP – Good Manufacturing Practice. An understanding of current best international GMP is imperative for each and every engineer working or looking to work in the pharmaceutical industry.
Programme
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The Role of the Engineer in the Pharmaceutical Industry
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Current International GMP Regulations and Regulatory requirements for Engineers- Core Requirements
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Controlled Documentation and Record keeping
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Change control
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Training
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Deviation and CAPA Management
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Equipment and Utility Qualification – An overview
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Retrospective qualification, Preventative Maintenance and Calibration programs
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‘GMP Hot Topics’ for Engineers- including the new FDA process validation guidance
Who should attend
This one-day CPD course will be of interest to all engineers working or looking to work within the Pharmaceutical Industry
Trainer's profile
Elizabeth Eggleston, Consultant
Elizabeth qualified with a first class honours degree in Chemistry from UCC in 2001. She joined McGee Pharma International in 2010 from the pharmaceutical industry, where she worked for 8 years with both small and large multi-national pharmaceutical companies. She has worked in a number of areas including: process development & scale up; technical support roles in API & OSD manufacturing including process & cleaning validation. Elizabeth has since obtained a M.Sc. Industrial Pharmaceutical Science from the Royal College of Surgeons in Ireland (RCSI) in 2011, fulfilling the Qualified Person (QP) eligibility requirements according to the EU Directive. Elizabeth has also managed and provided quality and technical oversight to third party contract manufacturing and packaging & supply chain operations for API, OSD and sterile finished products.