Overview
CAPA is the foundation of an effective Quality Management System.
Yet, many companies suffer from Death by CAPA - a slow, bureaucratic,
ineffective CAPA process.
Not only do they fail to achieve necessary improvements, they waste precious time and resources.
This webinar will help you avoid identify the symptoms of this common
problem. Learn how to avoid those struggles and establish an efficient
and effective CAPA 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 webinar is for you.
We'll discuss 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.
Why should you Attend
CAPA is the foundation of an effective Quality Management System. Yet,
it is frequently perceived as a burdensome and bureaucratic exercise,
resulting in "death by CAPA". Many companies struggle to establish and
maintain a CAPA program that is efficient and effective.
An ineffective CAPA System leads to disastrous consequences such as
medical device reports, recalls, 483s, and warning letters. And an
inefficient CAPA program results in wasted time, money, and missed
opportunities. In this webinar, we'll discuss the fundamentals of a CAPA
program and how you can make your CAPA program the valuable improvement
tool it is meant to be.
Areas Covered in the Session
- FDA and NB expectations for CAPA
- Lessons Learned from 483s and warning letters
- Common problems and simple solutions
- How to structure your CAPA process
- How to use tools to monitor and maintain your CAPAs
- Metrics to ensure your CAPAs are timely and effective
- A toolkit for CAPA
- Best Practices
- Inspection Readiness
Learning Objectives
- Overview of the Regulations
- FDA Expectations
- CAPA Process
- Lessons Learned and Common Mistakes
- Best Practices
- Preparing for an FDA Inspection
Who Will Benefit
- Quality Systems Specialists
- Document Control Specialists
- Quality and Compliance Specialists
- Internal Auditors and Managers
- Training Specialists
- CAPA Specialists
- 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
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.
Instructor
Susanne Manz
