Implementing an Effective CAPA System: cGMP, Root Cause Analysis (RCA), Investigation and Risk Assessment 2017

Topics

• The vocabulary of Investigation and CAPA
• The history and expectations for global regulators for Investigation and CAPA
• How to reduce bias while improving the approach to Event Investigation (Deviation / OOS / Non-conformance / etc.)
• The difference between the CAPA system and a CAPA
• The tools of investigation and how to apply them
• The difference and roles of both Risk Analysis and Impact Assessment in Investigation and CAPA
• The difference between the signals of an event and True Root Cause
• What GMP transactional mapping is and how to apply it to investigation, risk assessment and RCA
• Successful CAPA implementation plans
• Problem solving methods to help you asses select the best solution for the root cause
• How to prepare and present the Investigation and CAPA program to investigators during an inspection
• Why the Justification for the CAPA is equally important as the solution itself
• The many uses of CAPA beyond just closing deviations (CAPA as an Agent of Change )

Who should Attend

• Quality Professionals
• Executive Management and Senior Quality Managers
• Compliance Professionals
• Regulatory Professionals
• Manufacturing Engineers
• Production Managers, Supervisors and Operators
• Calibration, Preventive Maintenance and Production Engineers
• Warehouse Managers, Supervisors and Personnel
• Quality Engineers
• Process and Department Owners
• Deviation & CAPA System Personnel
• Quality Auditors
• Designated Investigators and Process Improvement Personnel