Implementing an Effective CAPA System: cGMP, Root Cause Analysis (RCA), Investigation and Risk Assessment 2017 is a conference that covers topics such as:
- 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 )
Implementing an Effective CAPA System: cGMP, Root Cause Analysis (RCA), Investigation and Risk Assessment 2017 brings together:
- 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
