Root Cause Analysis: Foundation of Investigations and CAPA is organized by GlobalCompliancePanel and will be held during May 16 - 17, 2018 at Philadelphia, Pennsylvania, United States of America. This CME Conferece has been approved for a maximum of 12 credits.
Who will Benefit:
This seminar will be of benefit to anyone working in a GMP regulated environment on global or domestic scale within the pharmaceutical and medical device industry. This includes quality, validation, engineering, manufacturing, and management personnel from sponsors and contract manufacturers (CMO) alike. This is anyone who wants to improve their ability to solve recurring problems should attend this training. Additionally, those who are actively involved in performing, overseeing, auditing, or managing investigations will find this course extremely beneficial.
• Quality Managers
• Operations and Manufacturing Personnel
• Product/Process Development
• Principal Investigators, Site Research Directors and Coordinators
• Quality Assurance Staff
• Regulatory Managers and Professionals
• Compliance Managers and Professionals
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
Additional details will be posted as soon as they are available.
Conference Fee Details
|Early Fee Last date||:||NA|