HOW TO WRITE SOP’S

One day course

Key Objectives:

• How to write concise and user friendly SOPs
• How to prepare the topic content of SOPs 
• Implement and manage SOPs effectively
• Effective SOP training
• Ensuring your SOPs include an appropriate level of  regulatory requirements
• Understand how to ensure SOPs incorporate appropriate regulatory requirements

PROGRAMME

How to Write Concise and User Friendly SOP’s

• When are SOPs needed and why?
• What is the difference between having SOPs and work instructions/local guidance?
• Format, content, style and presentation
• Translation of the activities into the SOPs
• Writing sufficiently detailed SOPs, but which are not restrictive
• Defining and writing SOP content using mind mapping and flow charting
• Writing an SOP on the format and layout of SOPs

SOP Implementation and  Management

• Review and approval processes for SOPs
• Handling updates – when should SOPs be updated and how?
• Distribution, version control
• SOP training
• How to maximise end user compliance
• Tips for what auditors and inspectors look for when they review SOPs

Ensuring your SOPs include Appropriate Regulatory Requirements

• What level of regulatory requirements should be in SOP's? 
• What topics should the SOPs cover?
• What needs to be included for compliance? - GXP areas including clinical research, pharmacovigilance, regulatory affairs and GMP