An Essential course for ensuring compliance with regulatory requirements
Particularly relevant for Pharmacovigilance, Regulatory Affairs, Clinical Research/Operations, GMP, QA and document management functions
SOPs play a crucial role in compliance with regulations. It is therefore essential that they are well written and easy to understand by the end-users. 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 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. It is essential therefore to have a number of SOPs, and for existing SOPs, to be reviewed and updated regularly. Otherwise this is likely to result in major findings by regulatory inspectors. Participants will come away with the confidence to use a process to write, update and implement SOPs which can easily be used by the end users.
Topics to be Covered Include:
- How to write concise and user friendly SOPs
- How to prepare the topic content of SOPs
- Implement and manage SOPs effectively
- Ensure you SOPs incorporate appropriate regulatory requirements
09.00 Registration and Coffee
09.30 Introduction and Objectives
How to Write Concise and User Friendly SOPs
- When are SOPs needed and why?
- Discuss the difference between having SOP, policy documents, work instructions and local guidance
Review and 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 limiting
- Understand 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
- Handline 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
17.00 Final Questions and Close
For more information about this conference visit http://www.researchandmarkets.com/research/nwcsgc/how_to_write_sops