Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends 2016 is a webinar that covers topics such as:
- 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
Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends 2016 is intended for:
- 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
