Death by CAPA - Does your CAPA Program need a CAPA?

About The Course:

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. It is critical that your company establishes a compliant, effective process. This seminar will also provide tools and checklists to ensure your program is inspection ready.

AREAS COVERED:

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 SHOULD ATTEND:

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
Quality/Compliance managers or directors for Medical Device companies
General Managers wanting to learn how to understand Quality System requirements
Management Representatives

AGENDA

DAY 1 (10 AM to 3 PM)
Lecture 1:

FDA expectations for CAPA
Lessons Learned from 483s and warning letters
Common problems with CAPA

Lecture 2:

Elements of a CAPA program
How to structure your CAPA process
How to use IT tools to monitor and maintain your CAPAs
Metrics to ensure your CAPAs are timely and effective

Lecture 3:

A toolkit for CAPAs

Lecture 4:

Sources of Data
Analysis of Data
Failure Investigation

DAY 2 (10 AM to 3 PM)
Lecture 1:

Root Cause Analysis

Lecture 2:

CAPA Project Management
Problem Solving and Improvement techniques

Lecture 3:

Effectiveness Checks
Control, Monitoring, Dissemination of Information
Connections within your Quality Management System
- Type testing
- Sample testing
- Software verification testing
- Inspections
- Analyses
Bullet-proof Reports

Lecture 4:

Inspection Readiness and Checklist
Best Practices

COURSE DIRECTOR: SUSANNE MANZ

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 an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Worldwide Director of Design Quality, and Director of Corporate Compliance. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. For more information, visit www.ManzConsultingInc.net.

2 Days CAPA Seminar