Good Manufacturing Practice and Packaging (2-day)


The packing process is a complex series of operations, often performed at high speeds and against tight deadlines. Despite the increased use of many on line detection/rejection systems, the majority of pharmaceutical quality complaints and recalls are packaging related.


This course gives a detailed background into the complicated issues associated with pharmaceutical packaging. It examines all of the key stages from artwork design, component suppliers through the packing process to final product release. It also examines the important role people play in packing operations.


It identifies major areas of risk and discusses how these can be removed or managed.


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Good Manufacturing Practice for Medical Devices (1-day)


The course covers the requirements of the Medical Device Regulatory Standard ISO 13485 and the regulatory framework and documentation required to market a medical device.


Those attending will get an understanding of the requirements and documentation required to market and maintain compliance for medical devices in the market place. There are tutorials on the Directives, the regulatory system, the marketing of a device and the ISO 13485 Medical Device Standard. Added to this there is an introduction to risk management and the vigilance system.


The course is interactive with many practical exercises and discussions.


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Good Manufacturing Practice in the Laboratory (1-day)


This course is an adaptation of our standard 1-day GMP course, designed specifically for laboratory staff who have unique, additional requirements laid out in GMP both in the European and USA regulations and guidance documents.


The pharmaceutical quality control laboratory serves one of the most important functions in the manufacturing environment. Many of the GMP regulations and guidances apply to control laboratories but in particular Chapter 6 (QC and Good Control Laboratory Practice) of the EU Guide to GMP. The course also covers the role of documentation, pharmacopoeias, laboratory reference standards, calibration, calculations and results. The final session of the course brings all this together with a session on preparing for regulatory inspection.


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“Excellent! Course content is comprehensive and detailed and feedback encourages relevance.”


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