Two Partners. Two Practical Principles. One Powerful Approach.
The Practical Solutions Group, LLC
152 Witherspoon St.
Princeton, NJ 08542
P: 609.683.0756
F: 609.683.0758

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

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