Developing, Deploying, and Managing Best Practices for Change Control in the Life Science Industry
Presented by Len Grunbaum
- Understand the basic concepts relating to “change control” and “standard operating procedures”
- Understand the operational impact of too much detail or not enough detail in change control SOP’s
- Learn what confirmatory compliance documentation change control SOP’s should contain
- Understand the roles and responsibilities related to change control and how they should be represented in change control SOP’s
- Gain knowledge of the applicability of detailed work instructions, templates, etc.
- Share real-world examples of the impact of ineffective change control SOP’s
Change Control in Validation Processes
Presented by Len Grunbaum
- Understand the basic elements of the change control process
- Understand the core relationship between system development, computer system validation and change control
- Understand the relative applicability of, and differences between, “re-validation” and “change control”
- Learn how to assess the regulatory compliance and operational impact of a change on a system’s validation status
- Learn about what constitutes effective change control tools
- Share real-world examples of the impact of ineffectively applied change control