Traininng.com LLC, Online Event
Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can we do this effectively?
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
Who Will Benefit
- VP of IT
- Director of IT
- 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 Directors of Commercialization
- Document Managers
- Training Managers
- Outsource Service Providers