SOPs and GMP Trainer Programme

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

The first day of this 2-day programme is the Writing SOPs Training course, which provides the opportunity to learn effectively, how to dissect a task down into a logical structure and sequence, write the SOP/working instruction and test it in use before approval.

The second day’s course, The GMP Trainer, places emphasis on individual learning and the often neglected area of training to SOPs. The course highlights that just reading SOPs is insufficient when it comes to a learner needing to learn a skill, as well as just understanding the task.

Learners investigate what the regulatory standpoint is and will then consider what tends to be the common practice. This then allows the learners to appreciate the importance of on-the-job training.

Course learners then consider how individual learning needs, will be met. This will then determine the best method of training to be provided. The aim is to propose the most suitable method for the business and the learner to ensure people are competent in their job role.

Day 1

• Understand the need for SOPs and working instructions in healthcare manufacturing industries 
  • Why have and use procedures?
  • Understand what an SOP/working instruction is 
  • Why some SOPs and working instructions are difficult to understand, use and are not readily accepted by the users
  • What makes an effective SOP/working instruction for GMP?
• Define where SOPs and working instructions fit within a Quality System
  • The lifecycle of douments from creation to retirement
  • How SOPs and working instructions fit in with other documentation
  • How to control and manage SOPs/working instructions 
• Create a process flowchart
  • Break down a task into logical steps
  • Create a flowchart from the logical steps
  • Provide a flowchart as the first part of an SOP
  • How flowcharts relate to work-based activities and processes 
• Create a simple SOP/working instruction
  • Use the flowchart to create a simple SOP 
  • Review the SOP for potential improvements
• Training and SOPs/working instructions
  • The importance of training to SOPs/working instructions
  • What regulators look for 
  • Different training documents to use

Day 2

• Review and consider, the training cycle and methods of training relative to SOPs in a workplace environment
• Look at regulatory compliance issues concerning SOPs and training, and understand the importance of recording training
• Recall the key areas of one-to-one training through self assessment, questioning and interactive group work
• Consider and address items that can affect learning, including equal opportunities, fair access and special requirements
• Realise how demonstration, instruction and training documentation enable effective and consistent training delivery
• Understand different approaches to learning evaluation, through investigating competence, questioning, listening, and observation
• Discuss revisions to SOPs / working instructions and how to assess levels of training requirements to such revisions

Please note: This is not a Train the Trainer Programme. If you are interested in an SOP and Train the Trainer Course, please visit SOPs and Training the Trainer.

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 ›