Author
Walid El Azab
Attendees:
This workshop is designed for professionals responsible for ensuring sterility assurance and controlling contamination in manufacturing operations. Key attendees include Contamination Control Strategist (CCS) leads, steility assurance manager, Quality Assurance and Quality Control managers, Microbiology and Environmental Monitoring personnel, Manufacturing supervisors, Process Engineers, and Quality Risk Management (QRM) specialists.
Abstract:
This practical one-day traing addresses a critical gap in pharmaceutical manufacturing: moving from fragmented data trending to a truly holistic and strategic view of Contamination Control Strategy (CCS) performance. In response to EU Annex 1's mandate for an integrated strategy, this session guides participants beyond isolated corrective actions. It focuses on the systematic design of a dynamic KPI dashboard that interlinks all critical control points—from environmental monitoring and facility design to personnel flows and utility systems. Through interactive exercises, attendees will learn how to select leading and lagging indicators, define meaningful correlations between different processes, and structure a visual management tool that transforms disparate data into actionable intelligence. The workshop empowers teams to shift from a culture of correcting contamination events to one of strategic prevention, enabling real-time performance monitoring, enhanced decision-making, and robust demonstration of a state of control for regulatory compliance and ultimate patient safety.
Learning Objectives:
Upon completion, participants will be able to:
- Define the strategic objectives of a holistic Contamination Control Strategy (CCS) as guided by EU Annex 1 and other relevant standards.
- Identify and select meaningful Key Performance Indicators (KPIs) across all critical control points, including design, procedural, technical, and organizational controls.
- Design a comprehensive dashboard that visualizes and interlinks KPIs from disparate data sources (e.g., EM, sterility tests, aseptic simulations, utilities, deviations) to provide a unified view of CCS health.
- Apply dashboard insights to transition from reactive, corrective actions to proactive, preventative control and continuous improvement of the CCS.
- Establish a monitoring framework to assess the ongoing effectiveness of the implemented strategy and demonstrate control to internal and external stakeholders.
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