Conference Description:

Course "Root Cause Analysis: Foundation of Investigations and CAPA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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

Registration Link - https://www.globalcompliancepanel.com/co ntrol/globalseminars/~product_id=901735S EMINAR?SEO