4-Hour Virtual Seminar on CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals

Overview:

This training provides a deep dive into the process, beginning with problem definition statement, data driven approach for root cause analysis followed by corrective /preventive action and methods to verify the effectiveness of the implemented solution. 

Why you should Attend:

This training covers CAPA requirements from regulatory and quality management standards, common root cause investigation tools, and how to prepare for an inspection /audit of the CAPA process. This program will provide a methodology to work through the entire root cause analysis process, from creating a data-based problem statement, applying root cause (RC) tools, and conducting data analysis for verifying the cause to selecting the best solution and determining its effectiveness. 

Areas Covered in the Session:

• CAPA and its purpose
• Terms to know: correction, corrective action, and preventive action
• CAPA requirements: regulatory and quality management systems 
• Defining problem statement, Measuring/Data based approach
• Root Cause analysis tools and Data analysis
• Selecting solutions based on data - corrective /Preventive actions
• Determination of effectiveness 
• Audit /Inspection readiness for CAPA process

Who Will Benefit:

• The training is intended for Managers and Specialists with Responsibilities for Investigation of Nonconformity/ Deviation and customer complaints related to regulated products/services. Individuals participating in problem solving and /or investigating root cause of a nonconformity at various organizational levels
• Quality Managers
• Production Managers
• Quality/Compliance Leads/Specialist
• Manufacturing Engineers
• Service Engineers