The GMP Training for Operators is a useful course for packaging and manufacturing organisations, both for new staff or those requiring a refresher.

The course is designed to minimise the operators’ time away from the workplace. Within the half day course, the important basics are covered through interaction and operator involvement.

This course can be delivered on-site for maximum benefit, providing the option of covering two sets of operators over one day. The training is also available as an open course delivered in hotels.

• Consider why GMP is so important for patients, healthcare regulators and manufacturers 
• Discuss and explain what GMP means
• Clarify the consequences of non-compliance to GMP for patients, regulators and subsequently the healthcare manufacturer
• Review of regular non-compliance problems e.g. labelling, contamination, not following procedures, missing documents etc.
• Briefly introduce who the main regulators are and the rules and regulations that healthcare manufacturers have to follow
• Learn and understand what standard operating procedures (SOPs) are and why they must be strictly followed and used during manufacturing and packaging
• Review of an SOP, why it is important to be trained against and used daily by operators in key critical tasks
• Keeping training records up-to-date
• Determine the effects of and differences between micro-biological contamination, cross contamination and foreign contamination
• A description of three types of contamination and what it means for operators, including the importance of clearing and cleaning between product changes
• Review of personal hygiene and gowning-up procedures and requirements
• Analyse the importance of good documentation practice and recall why it is so important
• Review examples of good documentation practice against poor practice
• Highlight the need for traceability when problems with product occur

ITS’ Regulatory Training Manager, Alan Benbow, has developed extensive knowledge of this specialist area from 22 years’ industry experience working with Johnson & Johnson, and Wyeth Pharmaceuticals.

During his 14 years at Wyeth, Alan was involved in a wide range of activities including, at operational levels, developing operators, craftsmen, and technicians; he was also responsible for training and assessing operational employees to NVQ standards. From a mid-management perspective, training and development initiatives included facilitating continuous improvement projects and best practices, and receiving internal recognition awards. more ›