6-Hour Virtual Seminar on Death by CAPA – Does your CAPA Program need a CAPA?

  • Product Id : MD3280
  • Category : , , ,
  • Presenter :
  • Scheduled On : July 25 2019 11:00 am
  • Duration : 6 Hours

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.

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 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

MD3280

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.

Lecture 1:
– 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

Lecture 2:
– A toolkit for CAPAs
– Sources of Data
– Analysis of Data
– Failure Investigation

Lecture 3:
– Root Cause Analysis

Lecture 4:
– CAPA Project Management
– Problem Solving and Improvement techniques

Lecture 5:
– Effectiveness Checks
– Control, Monitoring, Dissemination of Information
– Connections within your Quality Management System

    – Type testing
    – Sample testing
    – Software verification testing
    – Inspections
    – Analyses

– Bullet-proof Reports
– Inspection Readiness and Checklist
– Best Practices

membership

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.