In today’s highly regulated pharma, biotech, device and animal health industries, it is essential to use the most efficient processes and ensure compliance with an active corrective and preventive action (CAPA) and RCA system.
This course will cover CAPA and RCA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and RCA planning and implementation in practice of improvements.
Root cause analysis is the process by which we discover the underlying cause of difficulties in a business process or processes. Often businesses waste a great of money in fixing the symptoms of a problem, rather than the problem itself.
CAPA and RCA procedures are a frequent focus of regulatory inspectors and evidence will be required at any future inspections that CAPA actions have been implemented.
In this two-day course, participants learn to apply a systematic end-to-end process for analysing problems to uncover their root cause.
Who should attend?
This course has been specifically designed for those working in the pharma, biotech, device or animal health industries who are involved in CAPA and RCA requirements. Anyone with the need to improve their ability to solve recurring problems including:
• Managers responsible for process and quality improvements
• Professionals working in R & D
• Quality Managers, Internal and External Auditors
• Line managers and supervisors
• Anyone involved in managing customer and/or supplier/CMOs/CRO relationships
• Problem solving team members and leaders
• Product or process designers
• Production and process operatives
• Anyone working in QMS
• Project Managers
• Business Analysts
• Process improvement analysts
• Managers; supervisors, team leaders, and process users