Case Study: Resources for Validation/Commissioning project
Opportunity…
A large facility of a global pharmaceutical client received a Warning Letter which required the site to revalidate a significant portion of the manufacturing equipment.
Approach…
We deployed a Program Manager and a small number of Project Managers to organize and execute the equipment and process revalidation activities for the close to one-hundred pieces of equipment included in the Warning Letter.
- Our team developed detailed plans for each revalidation project.
- We developed an aggressive timeline and staffing plans.
- We supplemented the client resources with multiple validation teams to ensure the aggressive timeline was met.
- We bridged capability gaps on multiple client teams.
Outcome…
- The client completed the revalidation commitments three months ahead of schedule.
Project Examples
- For a medical device client, an SME supported the validation of all utilities for a plant expansion.
- For a biologics client, a small team validated multiple new autoclaves.
- For a pharmaceutical client, a small team validated multiple new packaging lines being deployed at the site.