The first day of this three day programme is the Introducing GMP (1 Day) Training course. This is a foundation or refresher course, useful for individuals who need to understand what Good Manufacturing Practice (GMP) means for healthcare manufacturers and subsequently their suppliers.

Day 2 of the programme is the Writing SOPs Training for the Healthcare Industry course, which provides the opportunity to learn effectively how to dissect a task down into a logical structure and sequence, write the SOP and test it in use before approval.

The final day’s course, Training Essentials, considers training relative to SOPs, regulatory compliance and associated issues. Individual learner’s requirements are reviewed with different techniques for delivering training. The aim is to propose the best suitable methods for the business and the learner to ensure people are competent in their job role.

Day 1

• Understand the need for GMP
• What is GMP?
• GMP and its link with Quality Assurance and Quality Control
• Define the GMP guidelines and how agencies enforce them
• What are the relevant regulations?
• How the main regulatory agencies audit and enforce them
• Investigate the 4 Ps
• People - adequacy, experience, training and the role of the Qualified / Responsible Person
• Procedures and Documentation - from the completion of SOPs to in-process controls
• Production Areas and Equipment - premises, layouts and considerations
• Products and Components - incoming, handling, storage, packaging, labelling and non-conforming products
• Identify potential GMP violations and their consequences
• Use interactive case studies to analyse scenarios
• Examine real reported incidents
• Determine behaviours that improve GMP
• Plan for workplace improvements

Day 2

• Understand the need for SOPs in healthcare manufacturing industries
• Why have and use procedures?
• Understand what an SOP is
• Why some SOPs are difficult to understand and use and not readily accepted by employees
• What is and what makes an effective SOP for GMP?
• Define where SOPs fit within a Quality System
• The lifecycle of documents from creation to retirement
• How SOPs fit in with other documentation
• How to control and manage SOPs
• Create a process flowchart
• Break a task down 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
• Use the flowchart to create a simple SOP
• Review the SOP for potential improvements
• Use pictures and images within SOPs
• Pictorial SOPs and healthcare regulatory requirements
• Will they be used?
• Understand about training to SOPs
• The importance of training to SOPs
• What regulators look for
• Different training documents to use

Day 3

• 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 and how to assess levels of training requirements to such revisions

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 ›