Standard operating procedures (SOPs) play a crucial compliance role with regulations. It is therefore essential that they are well written and easy to use. If SOPs are not followed correctly, the validity of data generated is compromised, leading to inspection findings and non-compliance issues which could lead to delays in bringing a drug/device to market.
This interactive SOP course has been specifically designed to help you develop the skills to write and produce the content of SOPs using a best practice process including process mapping, review and implement SOPs and ensure you comply in a regulated environment.
You will come away with the confidence to use a best practice process to write, update and implement effective SOPs.
Benefits of attending:
- Master the art of writing user-friendly SOPs
- Learn how to prepare the content of SOPs including process mapping
- Discover how to implement and manage SOPs effectively
- Carry out effective SOP training
- Ensure your SOPs incorporate appropriate regulatory requirements
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Agenda
Fundamentals of effective SOPs
- When are SOPs needed and why?
- The difference between SOPs, policy documents, work instructions and local guidance
- Determine the scope, roles and responsibilities associated with SOPs
- Identify the essential structure of SOPs
- Share best practice: what makes a good SOP?
- Identify who should write, review and authorise SOPs
- Current thinking in writing SOPs
- Application of process mapping for writing SOPs
- Example of a best practice 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 limiting
- Understand the target audience and account for end users’ needs
- Tips for how to write the content, format, style and presentation
- Defining SOP content using mind-mapping and process-mapping/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 SOP using best practice methodology
Practice preparing an SOP
Ensuring Your SOPs meet regulatory requirements
- What needs to be included for compliance in GxP areas?
- Current regulatory trends
- Tips for what auditors and inspectors look for when they review SOPs
Speakers
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
Who Should Attend
- All those in pharma, biotech, generics, devices and animal health industries who are involved in preparing, reviewing and/or managing SOPs
- Ideal as an introduction and also helpful to those wanting to ensure they are aware of best practice
- Particularly relevant for those in GxP areas including clinical research, pharmacovigilance, QA, regulatory affairs and GMP
