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

This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.

Course Description/Agenda

This 6-hour virtual 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 expectations, 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 virtual seminar provides 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.

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

Agenda

- - Using lecture, discussion, case studies, and break-out groups, this seminar will provide you with the tools to create an effective and efficient CAPA program. Topics to be covered include:
    
    FDA expectations for CAPA
    
    Lessons Learned from 483s and warning letters
    
    Common problems with CAPA
    
    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
    
    A toolkit for CAPAs
    
    Sources of Data
    
    Analysis of Data
    
    Failure Investigation
    
    Root Cause Analysis
    
    CAPA Project Management
    
    Problem Solving and Improvement techniques
    
    Effectiveness Checks
    
    Control, Monitoring, Dissemination of Information
    
    Connections within your Quality Management System
    
    Non-conforming Product
    
    Corrections and Removals
    
    Change Control
    
    Statistical Techniques
    
    Risk Management
    
    Bullet-proof Reports
    
    Inspection Readiness and Checklist
    
    Best Practices

Instructor:

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, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne 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 Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

More Webinar Information

Global Compliance Panel
Course Summary	This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company.
Delivery Method	Virtual Classroom (Live)
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