This Standard Operating Procedure (SOP) course has been specifically designed to help you develop the skills to write and produce the content of SOPs, review and implement SOPs and ensure you comply in a regulated environment. You will come away with the confidence to use process to write, update and implement SOPs which can easily be used by the end users.
Attend this programme will show you:
- How to write concise and user friendly SOPs
- How to prepare the content of SOPs
- Implement and manage SOPs effectively
- Carry out effective SOP training
- Ensure your SOPs incorporate appropriate regulatory requirements
How to write concise and user friendly SOPs
- When are SOPs needed and why?
- Discuss the difference between having SOPs, policy documents, work instructions and local guidance
Review the fundamentals of SOPs
- Determine the scope, roles and responsibilities associated with SOPs
- Identify the essential structure of SOPs
- Discussion to share best practice: Review of what makes a good SOP
- Identify who should write, review and authorise SOPs
- Current thinking in writing SOPs and an example of a good SOP
Write concise and user-friendly SOPs
- Translate the flow of operations into the document
- Write SOPs that are sufficiently detailed, but not restrictive and limitingUnderstand the target audience and account for end user’s needs
- Tips for how to write the content, format, style and presentation
- Defining SOP content using mind mapping and flow charting
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
- Exercise: Write an example SOP
Ensuring your SOPs meet regulatory requirements
- What needs to be included for compliance in GMP areas?
- Current regulatory trends
- Identify common SOP deficiencies
- Tips for what auditors and inspectors look for when they review SOPs
Dr Laura Brown,
Pharmaceutical Management and Training Consultant ,
University of Cardiff
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA.
She has more than 19 years experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing. Laura has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Board of the Good Clinical Practice Journal. In addition to her scientific qualifications, she has a degree in psychology and an MBA.
Laura is co-author of several books on management including Developing the Individual, The Ultimate Book of Business Skills and Pharmaceutical Project Management.
- All those in pharma, biotechnology, generics, devices and animal health industries who are involved in preparing, reviewing and/or managing SOPs
- Ideal as an introduction to preparing, reviewing and implementing SOPs and may also be helpful to those wanting to ensure they are aware of best practice
- Particularly those in GXP areas including clinical research, Pharmacovigilance, QA, regulatory affairs and GMP
The Cavendish Hotel
81 Jermyn Street