3-Hour Virtual Seminar on CAPA for Medical Devices

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 180 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 180 Min Live Webinar

"Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma"

CAPA is the cornerstone of an effective Quality Management System

Description

This 180-minute webinar will focus on how to improve your CAPA process to optimize efficiency and effectiveness, This webinar 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.

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems 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. In this 3-hour webinar, 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 cornerstone of an effective Quality Management System. Yet, it frequently perceived as a burdensome and bureaucratic exercise. 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 more efficient and more effective. 

Learning Objectives:

  • Understand the regulatory requirements
  • Creating an efficient and effective process
  • Linkages to your Quality Management System
  • Myths, Challenges, and Best Practices
  • Inspection preparedness

Areas Covered

  • FDA and NB expectations for CAPA

  • Lessons Learned from 483s and warning letters

  • CAPA Process

  • Common problems CAPA

  • How to structure your CAPA process for effectiveness and efficiency

  • How to use IT tools to monitor and maintain your CAPAs

  • Metrics to ensure your CAPAs are timely and effective

  • A toolkit for CAPA

  • Best Practices

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

Industries who can attend

This 180-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

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, WW Director of Quality Engineering and, 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. 

Specialties: Quality, Compliance, Six Sigma, Lean Sigma, Quality Systems Development, ISO13485, ISO14971, GMP, QSR, CFR820, Quality Systems Auditing, Supplier Audits, Due Diligence, Predictive Compliance,Training and Education, FDA and Notified Body Inspection Readiness, Risk Management and Mitigation, Management Review, Quality Improvement, Supplier Management, Supplier Auditing, Process Validation, Problem Resolution, 483 / Warning Letter responses and mitigation.

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