This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.

We'll discuss regulatory requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We'll discuss best practices so you can start off on the right foot and always be prepared for an inspection.

This seminar will provide detailed lectures on all elements of a CAPA program and how they connect to other parts of your Quality Management System. You will learn how to create a CAPA program that results in improved product quality, reduction in compliance issues, and ultimately leads to improved business success.

Why you should attend:

Corrective and Preventive Action (CAPA) is the cornerstone of a strong Quality Management System. And yet, many medical device manufacturers struggle to establish and maintain an effective CAPA process. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters. Additionally, an inefficient CAPA system leads to wasted time and resources.

CAPA is so important that it is always emphasized in FDA inspections. It is consistently one of the top reasons for 483 and Warning Letter observations. More importantly, CAPA is critical for an effective Quality Management System to ensure safe and effective products. It is critical that your company establishes a compliant, effective, and efficient process. This seminar will also provide tools and checklists to ensure your program is inspection ready.

Areas Covered in the Session:

• Regulatory Requirements and expectations
• Elements for creating an efficient and effective CAPA Program
• CAPA process, tools, and techniques
• Linkages throughout the Quality Management System
• Root Cause Analysis
• Metrics, Control, and Monitoring
• Dissemination of Information
• Myths, Challenges, Best Practices
• Inspection Preparedness

Who Will Benefit:

• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Quality Engineers
• Internal Auditors and Managers
• Training Specialists
• CAPA Specialists
• CAPA Managers
• Supplier Quality Engineers and Auditors

Susanne Manz

Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc.
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.