Quality & Validation Remediation Project

Challenge

Our client, a leading global pharmaceutical company, had several key sterile manufacturing sites put into remediation following an FDA warning letter. We met with the leadership team at the site in Kansas St louis and North Carolina to discuss exactly what Regulatory Compliance solution they needed.

Consulting Services

Solution


Working together, we quickly identified that the client required industry-specialist support across four key workstreams: CAPA, Deviation Investigation, Change of Control & Validation. Due to the location of the facility, local options that delivered the niche expertise required were impossible. Cost was also an issue as the client was working to a tight budget. A final challenge was the need to ensure that the team was not only rapidlydeployable but also retainable for a minimum of 12 months to ensure project continuity.

Proclinical’s unique costing structure ensured we won the bid for this work exclusively by making it clear that results could be provided within-budget whilst still meeting the short time-frame. Proclinical utilized a delivery team to provide pre-qualified specialist support in less than 14 days. Our delivery team was exclusively committed to the project, allowing the time to focus on every hire. Each candidate was stringently vetted for sterile experience and long-term commitment to the project. We ensured this by adding a second layer to the interview process by bringing in an external industry professional to conduct an extra interview prior to any submission to the client.

We also utilized an in-country solution to ensure each team member was mobilized, supported effectively and ready to work when arriving into the country. Thanks to an excellent partnership with the management structure at the plant, Proclinical was also able to provide a team of people for each workstream that settled quickly and seamlessly into the existing workforce, minimizing disruption.

Outcome


  • Workforce retention rate was 92%
  • Peak headcount on the project was 34
  • Site was successfully moved out of remediation ahead of time and under budget
  • Testament to our sourcing methods, 13 consultants remain on-site to ensure best practice for prevention

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