Non-conforming Materials and Failure Investigations for Medical Devices

Why Should You Attend:

Dealing with non-conforming material is a necessary process for medical device manufacturers. Yet, non-conforming material is a top reason for 483 and Warning letter citations. Even worse, problems in managing non-conforming material can lead to quality problems including complaints, medical device reports, and even recalls. In this webinar, we’ll discuss the requirements for successfully managing non-conforming material and conducting failure investigations.

Learning Objectives:

• Overview of the Regulations
• FDA Expectations
• Non-conforming material
• Segregation, control, and disposition of NC material
• Failure investigation requirements
• Correction and corrective action
• Documentation requirements
• Lessons Learned and Common Mistakes
• Preparing for an FDA Inspection

Areas Covered in the Webinar:

This 90-minute webinar will clarify the confusing regulations for non-conforming material. Topics to be covered include:

• Overview of the Regulations
• Definitions and expectations
• Acceptance activities
• Segregation and control
• Disposition types for NC material
• Concessions
• Failure investigations, when and how
• Correction and corrective action
• Documentation requirements and records
• Lessons Learned and Common Mistakes
• Preparing for an FDA Inspection

Who Will Benefit:

• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Internal Auditors and Managers
• Quality Engineers
• Manufacturing Managers
• 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

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

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, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. 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, Manz Consulting LLC, 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.

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