For regulated healthcare companies, whether they manufacture, are in research and development, in logistics or even a part of the National Health Service, their regulators are becoming more stringent than ever in determining protection for the product and patient.

A recent report from 2010-2011 indicated that the FDA had issued seven CGMP non-compliance training citations in different warning letters. The FDA does not issue warning letters lightly and considers all issues listed as very serious.

A few examples of the citations are listed here:

”When presented with an unsigned SOP entitled ’Training’ which requires CGMP training of employees, both the General Manager and the Production Supervisor stated that they were unaware of this document."

”In your response of XXXX, you state that your firm will revise its training program to provide and track employee training in CGMP and specific job functions. This response is inadequate in that it fails to state when the training will be completed. It also fails to explain the measures you will take to ensure product quality while operations continue with employees not adequately trained."

”We recommend that you hire a qualified consultant to provide comprehensive CGMP training … . Further, we recommend that once the training is completed, you conduct a comprehensive evaluation of all of your written procedures to ensure they are adequate, complete, and in compliance with the CGMP regulations."
 
Training citations are not new and past history shows that regulators consistently find fault with training, yet companies still get caught out! 

You might not necessarily work in a manufacturing environment, you may work in regulatory affairs, clinical trials or a totally different healthcare environment such as the NHS, but delivering structured consistent training to your own standard operating procedures and/or work instructions, policies etc, could be deemed as critical to the product and/or patient.

Don’t neglect your training, enrol onto the Train the Trainer for the Healthcare Industry course, which can be delivered either at an open venue or why not consider having the course delivered at your site?

You will be expected to deliver a short training session on the second day of the course to one of the other learners. This will require you identifying a work-based task for the training session: we will provide you with help and guidance on this before you attend. During the first day, you will build a training plan for delivering your own training, with help being provided from the Trainer.

The first day of the Train the Trainer for the Healthcare Industry course focuses on how we all have individual preferred learning styles which we all use to one extent or another.  These learning styles will be taken into account when you create and write your own training plan. In the training plan you will consider and build in how to train and assess your learners, including design and use of questions.

The training also allows you to learn how internal and external factors can have a negative impact on your training; the Trainer will provide you with guidance on how you can prevent and overcome these factors.

The second day is focused on you and the other learners carrying out training sessions, with help and support from our Trainer. You will also complete a compliant documented training record of the training event and following each session our Trainer will provide you with individual private feedback to assist in your long-term work-based development.

Day 1

• Understand 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 training to small groups of learners
• Consider and address items that can affect learning in a healthcare 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 work-based topic training session using a generated instruction plan and training plan
• Assess learners under instruction through observation and questioning, and provide feedback

“Very well presented using a relaxed and friendly approach that aided learning.”
IMA UK Ltd

“The trainer carried out the course in a clear and well structured way.”
IMA UK Ltd

"A very good course well presented by Alan. Alan made everyone on the course relaxed and at ease.”
IMA UK Ltd

"Well run and interesting course.”
IMA UK Ltd

"Very well presented and worked to suit peoples's needs.”
IMA UK Ltd

“Well presented.  Good overall course.  Met all the criteria needed.” 
Lodige Integral

“Very good course, enjoyed it and learnt a lot.”
Lodige Integral

“The course will be very beneficial in future training of site staff.”
TMG Marchesini UK Ltd.

"Extremely useful and applicable training which is invaluable.”
TMG Marchesini UK Ltd.

"Excellent course, well presented.”
Carmichael Engineering

“Excellent course.  Delivery was perfect, not too much or fast.  Help and advice always given.  Completion of NVQ is a must.” 
Jacob’s Bakery Ltd.

“Learnt a lot about myself and how to reflect on others.”
Jacob’s Bakery Ltd.

"Very good week. Learnt a lot about myself and how to reflect on others.”
Jacob's Bakery Ltd.

"Was very informative and would encourage me to take part in any future courses.”
Jacob's Bakery Ltd.

"I found the course very useful and what I've learned I will put into practice.”
Jacob's Bakery Ltd.

"Good course giving me more confidence to give a training session.”
Jacob's Bakery Ltd.

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 ›