• Determine the importance of GMP for patients, healthcare regulators and manufacturers and describe why individuals must comply with GMP
• Discuss and explain what GMP means
• Clarify the consequences of non-compliance with GMP, for patients, regulators and subsequently the healthcare manufacturer; review of common non-compliance problems e.g. labelling, contamination, not following procedures, missing documents etc
• Briefly introduce the main regulators and the rules and regulations that healthcare manufacturers have to follow
• Determine the effects and difference between micro-biological contamination, cross contamination and foreign contamination
• A description of three types of contamination and what they mean for operators, including the importance of clearing and cleaning between product changes
• Review of personal hygiene and requirements of gowning-up procedures
• Recognise the industry requirements for documentation, its importance and what good documentation practice entails
• Emphasis is given to the need for traceability when problems with product occur
• Review of examples of best documentation practice compared to poor practice
• Consider why people must be trained to Standard Operating Procedures (SOPs) and use them daily in their jobs

This course can be delivered to a group of up to 30 delegates at your premises. Request a quote for an onsite course.

ITS offers onsite training courses delivered by an English-only speaking trainer for companies in Europe and Worldwide. ITS has delivered courses to delegates from a number of countries including Belgium, France, Germany, Ireland, Jordan, Russia, Sweden and Switzerland.

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 ›