We’ll discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We’ll discuss the CAPA best practices so you can start off on the right foot and always be prepared for an inspection. This webinar will help you use CAPA as the important improvement tool it was meant to be.
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 and effective CAPA process. An ineffective CAPA process leads to disastrous consequences like complaints, recalls, 483s, and warning letters. Additionally, an inefficient corrective and preventive action procedure leads to wasted time and resources. For some companies, CAPA becomes a bureaucratic maze instead of a key improvement tool.
This 90-minute webinar will focus on how to improve your CAPA process to optimize efficiency and effectiveness. Topics to be covered include:
· FDA and NB expectations for CAPA
· Lessons learned from 483s and warning letters
· CAPA requirements and common problems
· An effective CAPA program
· How to structure your corrective and preventive action procedure
· How to use IT tools to monitor and maintain your CAPAs
· Metrics to ensure your CAPAs are timely and effective
· A toolkit for CAPA
· CAPA best practices
Many medical device companies experience “Death by CAPA”, a cumbersome, bureaucratic corrective and preventive action procedure. Instead of getting desired improvements, they waste precious time and resources. 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. If you’re experiencing Death by CAPA, this webinar is for you.
· 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 Med-ical Device companies
· General Managers wanting to learn how to under-stand Quality System requirements
Years of Experience: 30+ years
Areas of Expertise: Quality and Compliance for Medical Devices
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.View all trainings by this speaker