Perhaps if everything always executed as planned then we would not need procedures, but this is not the case in the real world. An SOP or Standard Operating Procedure is used to ensure business processes are well thought through, that each task in a process is performed the same way every time, and important data is recorded, along with errors or deviations so corrective action can be taken. Standard operating procedures used in combination with planned training and regular performance feedback lead to an effective and motivated workforce.
Managers and advisers benefit from consistent work performance and predictable results. Workers benefit from increased confidence and a clear sense of achievement. Producing a high-quality product at a profit depends on the consistent operation of all systems within the company.
SOPs describe the basic systems shared by all company employees. Company success depends on how well these systems work together to produce large volumes of high-quality product that is safe and effective for patients and consumers.
Good procedures and work instructions provide a way to communicate and apply consistent standards and practices within your organization.
Areas Covered in the Session:
What is an SOP
When to have an SOP
Who writes SOPs
What the SOP should say
The SOP template
SOP review and Approval
Active SOP maintenance
Training the staff on SOPs
- Quality Managers
- Project Managers (for CSV / IT)
- Validation Specialists
- Database Administrators
- System Administrators
- Directors /Senior Directors of Discovery
- Directors /Senior Directors of Development
- Directors /Senior Direc