Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends 2016

Key Topics

• How to facilitate a product complaint investigation as part of your CAPA program
• How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria
• How to conduct an investigation using a well-written CAPA policy and procedure
• What is a closed-loop investigation…cradle to grave approach
• Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice
• Understand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutions
• Develop and deploy escalation rules and criteria to facilitate decision-making process
• Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions
• Review and discuss recent CAPA red flags and FDA enforcement actions
• Understand what it takes to conduct a "quality" investigation to ascertain the root cause

Who should Attend

• QA/QC/CAPA Coordinators/CAPA Specialists
• All levels of Management for all departments and those who desire a better understanding or a "refresh" overview
• Engineering/Technical Services/Operations
• Regulatory Affairs and Compliance
• Consultants