Avoiding Death by CAPA – What you need to know

Duration 90 Mins
Level Basic & Advanced
Webinar ID IQW19F0679

  • Overview of the Regulations
  • FDA Expectations
  • CAPA Process
  • Lessons Learned and Common Mistakes
  • Best Practices
  • Preparing for an FDA Inspection
  • 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

Overview of the webinar

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.

Who should attend?

  • 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

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.

Faculty - Miss. Susanne Manz

Susanne Manz 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. She 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.

 

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