The GMP Trainer Course

The GMP Trainer Course can be delivered in a hotel, one of our offices, or your premises. The course content can be tailored to meet your requirements.

Pharmaceutical and medical device manufacturers spend considerable sums of money on purchasing high quality processing, packaging equipment and IT applications. Yet all this good work and investment can be put at risk if the company neglects the importance of effective training for the end users on such equipment and applications.

Experience has shown us that ‘reading an SOP’ then signing to say that you have understood it doesn’t mean that you can effectively go and carry out a task competently, does it?

What do the regulators think about it? Do they take it seriously? You can bet your life they do?

FDA February 2011 Warning Letter statement:
‘We expect that operators who conduct operations within aseptic processing areas be properly trained and monitored to ensure that proper aseptic techniques are utilized during all operations.’

A different FDA February 2011 Warning Letter statement:
‘You stated that the root cause was due to negligence of the tester and that all staff making tests and validation would be retrained in the requirement of always saving data.’

The emphasis in ‘The GMP Trainer’ programme is on the practical delivery of training to SOPs/Work Instructions rather than to vague tasks that are non-GMP related.

Please don’t neglect your own training and put your business at risk to manufacturing faulty products and potential regulatory action. Enrol on our ‘The GMP Trainer’ programme and do the training right first time!

Day 1

• Identify how learning styles can affect learning
• Recall the key areas of one-to-one training through self assessment, questioning and interactive group work
• Identify how to deliver effective GMP compliant training to small groups of learners
• Consider and address items that can affect learning in a GMP manufacturing operation
• Write an instruction and training plan based on real work-based topics, for training delivery

Day 2

• Employ a range of questioning techniques to assess learners under instruction
• Understand the importance of listening skills during the training process, particularly when faced with different healthcare manufacturing environments  
• Deliver a GMP work-based training session using a generated instruction plan and a training task breakdown plan
• Assess learner under instruction through observation and questioning
  

This course can be delivered to a group of up to 12 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 ›