6th Signal Detection, Root Cause Analysis and CAPA Summit 2016

Topics

• Ways to prepare for inspections and determine a course of action when dealing with inspection findings
• Tools, challenges and considerations for the implementation, verification and validation of CAPAs
• Proactive risk management to prevent the cause of nonconformities in pharmaceutical and medical device companies
• Root cause analysis and CAPA implementation in big vs. small companies
• Vendor and technology management in the CAPA landscape, and ways to address systemic vs. non-systemic issues

Who should Attend

• R&D Compliance
• Quality Assurance/Quality Control/Quality Compliance
• Clinical Auditing
• GCP Compliance
• Regulatory Affairs
• Quality Systems/Processes
• Quality Training
• Clinical Development/Operations
• Clinical Monitoring
• Data Management/Data Analysis
• Validation
• Post-Market Compliance
• Pharmacovigilance Quality Assurance
• CMC
• Compliance/Quality Assurance/GCP Consultants
• Continuous Improvement
• CAPA Systems Management
• Data Management and Quality Systems Management
• Trial Master File Professionals
• Audit Tracking and Management
• Metrics Professionals