Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and six sigma. She has worked at industry-leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 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 CQA (Certified Quality Auditor) 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. Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
Best Practices for Managing an FDA Inspection
Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you prepare for and manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your qu..
Essentials of Root Cause Analysis for CAPA
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We’ll also cover the essentials of doing a failure investigation.Areas Covered This 90-minu..
Internal Audit for Medical Device Companies
Internal Audit should be a key part of self-awareness and understanding strengths and weaknesses within your Quality Management System. It should be an essential guide to corrective and preventive action and drive improvement. But it doesn’t always work that way. In this webinar, we’ll cover the reasons internal audit doesn’t work and how you can correct that. This webinar will explore how to improve your i..
Medical Device Recall Management
Despite best efforts, serious quality issues resulting in the recall can occur. Medical Device companies need to be prepared in advance to handle a difficult situation. This webinar will prepare you to understand the signals that trigger a need to recall, the investigation and other actions required, taking corrective and preventive action, and notifications to customers and regulatory bodies.This webinar w..
Purchasing Controls and Receiving Acceptance for Medical Devices
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ ..
Write It Right – Well Written Procedures Are Essential For QMS Effectiveness
The webinar will help you to write clear, unambiguous, and flexible SOPs. You will learn techniques for creating easy-to-read and understand SOPs that your employees can consistently follow.Well-written procedures are a critical ingredient in an effective and efficient quality management system. They are an essential part of meeting the regulatory requirement to “establish and maintain” a suitable and effec..
Writing SOPs to Enhance Understanding and Compliance
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective. You will learn techniques for creating concise and easy-to-read SOPs that your employees can understand and will follow. Well-written SOPs result in more consistent process output an..