Root Cause Analysis: Foundation of Investigations and CAPA 2018

Root Cause Analysis: Foundation of Investigations and CAPA 2018 is a seminar that provides knowledge on how to investigate serious and complex incidents and events.

Topics

• Four Phases of RCA
• What do the regulations say?
• Expand the range of tools available for analysis of problem situations
• Promote the ability to provide problem-solving support in situations where one is not an expert in the process or technology involved
• Learn how to investigate serious and complex incidents and events
• Apply a variety of tools to narrow down the possible causes of a problem
• Learn how to identify root causes (not just causal factors) using proven techniques
• Learn the importance of near-miss investigations, incident classification, and data trending
• Understanding of the major cause categories that can affect your processes - and which categories tend to be the most overused and underused
• A robust investigation and root cause analysis process, as well as, basic root cause analysis tools that can transfer to any company
• The ability to identify the true cause of an issue and, as a result, identify and implement more effective CAPAs
• How to identify whether you’re finding the direct or the root cause of a problem
• Apply performance management concepts in case studies with a focus on prevention and issues management
• Tips for implementing a root cause analysis training program at your facility - and what support is required for the process to work once people are trained
• Identify examples of corrective action planning for different site noncompliance case scenarios
• Recognize components of effective corrective action planning and documentation
• Develop, establish, implement, and maintain effective root cause analysis and CAPA procedures and other documentation
• Discuss successful preventive action planning and implementation
• Attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
• Discussions on proper CAPA system maintenance, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan
• Review and discuss pain points, challenges and solutions
• Challenges and possible solutions will be discussed, and examples will demonstrate how the requirements can be put into practice
• Do you know how to identify root cause and how to close out your investigation?
• Are you in compliance with the FDA Corrective and Preventive Action (CAPA) requirements?
• Understand that the cost of regulatory noncompliance remediation is significantly greater than the cost of compliance