Have you been asked to create and write a Standard Operating Procedure (SOP)? Are you a newcomer to SOPs, never written one or had to use one before? Seems a bit daunting doesn’t it?

Why are they considered to be crucial for the healthcare professions? If you work in healthcare, in manufacturing, clinical or medical services with the NHS, there is no escaping them; organisations must have a comprehensive set of SOPs covering critical tasks that may ultimately affect the patient.

From a compliance viewpoint it is very important. Why? NHS professionals must adhere to The Controlled Drugs (Supervision of Management and Use) Regulations 2006, and also evolving requirements for the Research Ethics Committee in clinical trials.  

Manufacturers have to follow the relative country’s stringent regulatory requirements as per their marketing authorisation, such as the FDA’s Code of Federal Regulations, the EU’s GMP Volume 4 of “the rules governing medicinal products in the EU”, and others too.

We suggest you do not leave it to chance and take the time and 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.  Why not attend our course below?

The 2-day How to Write SOPs course builds on the 1-day course by developing the theme and incorporating additional investigation into using pictures and diagrams in SOPs. Furthermore, it explains how to utilise and integrate SOPs within an organisation’s culture – frequently a difficult undertaking.

• 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?
• Effectively use SOPs in manufacturing and packaging environments
• How do we influence people to use, follow and train with them?
• Using visual information and SOPs to achieve the maximum effect
• Training and SOPs
• The importance of training to SOPs
• What regulators look for
• Different training documents to use

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 ›