Regulatory Inspection Preparation Addresses Key Compliance and Production Issues

Case Study #12_Inspection Readiness

After a few years of compliance issues, our Global Pharmaceutical client retained the services of the Brevitas team to provide strong leadership and project management support in preparing their staff for a regulatory inspection.

Industry

Pharmaceuticals

Area of Expertise

Compliance & Operational Effectiveness

Duration

5 months

Services Provided

  • Program/Project Management
  • Technical Documentation
  • Organizational Change Management

Impact

Immediate actions not only prevented further compliance issues but also addressed production issues to enable our client to continue supplying products to global markets.

Business Challenge

Our client is a leading Global Pharmaceutical Company whose goal was to ensure that their staff was prepared for a regulatory inspection. The challenge was to conduct a thorough review of previous citations and observations, develop and track key performance metrics, and ensure that Subject Matter Experts (SMEs) were adequately prepared for their meetings with inspectors.

Our Approach

We enabled preparation for a major regulatory inspection by conducting a complete lifecycle management of the inspection readiness and associated change management activities through communication and stakeholder management. We conducted key activities that included prioritizing critical resources and managing SME workload. By working with both internal and external stakeholders, our consultants successfully tracked key metrics, addressed training gaps and created weekly communications for leadership to help build employee momentum.

Results Achieved

From inception to completion, the Brevitas team contributed to the success of the project by:

  • Managed over 80 position papers and presentations around critical topics and issues;
  • Conducted training sessions for individuals who were called into audit ;
  • Organized and tracked the status on approximately 100 pre-requests from inspectors;
  • Supported logistics of inspection;
  • Provided an exhaustive “lessons learned” report to key managers and directors, and recommendations on how to improve performance for future regulatory inspections.

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