4-Hour Virtual Seminar

4-Hour Virtual Seminar - Death by CAPA - Does your CAPA Program need a CAPA?

Product Id : 11910

Duration: 4 Hours

Instructor: Susanne Manz

Price Details +

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Overview

This 4-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.

Learning Objectives:

Understand the regulatory requirements
Elements of creating an efficient and effective program
CAPA process, tools, and techniques
Linkages to your Quality Management System
Myths, Challenges, and 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
Quality/Compliance managers or directors for Medical Device companies
General Managers want to learn how to understand Quality System requirements

Agenda

Using lectures, discussions, 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

Speaker Profile

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.