CAPA: The Driving Force behind Quality Management 

Date: Tuesday, September 16, 2014
Time: 11:00am ET / 4:00pm GMT / 5:00pm CET

The FDA has been actively enforcing CAPA requirements and reported that 50% of the top 10 FDA 483s are CAPA related.

In pharmaceutical industries today, companies are facing strong pressure from regulatory bodies as well as from the industry itself to focus on quality and increase efficiencies and lower cost as much as possible. A corrective and preventive action (CAPA) solution is one tool to achieve these objectives.

A CAPA solution with rigorous management of complaints and/or incidents drives continuous improvement and compliance benefits, which can help companies to:

  • Reduce the risk of lost or incomplete data
  • Facilitate compliance including ISO 9001 and 14001; 21 CFR parts 11, 210 and 211; ISO/IEC 17025:2005 and other international standards 
  • Provide a flexible yet controlled environment through fully configurable CAPA process workflows
  • Reduce the risk of repeat issues by ensuring that defined CAPA solutions and CAPA processes are followed
  • Decrease cycle time and production/operation costs by increasing CAPA process efficiency
  • Improve the efficiency of quality and operating processes by integrating your CAPA management software with other enterprise-level control systems such as document management software (DMS), enterprise resource planning (ERP) systems and laboratory information management solutions (LIMS)

Join us as we discuss the essential elements for implementing an effective CAPA system to help increase patient safety.

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