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Validity : 05th Jan'25 to 15th Jan'25
Non-conforming Material and Failure Investigations
- 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
Overview of the webinar
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material.You’ll learn where non-conforming material can occur and how to identify, segregate, control, and disposition non-conforming material.You’ll learn about when and how to conduct failure investigations and requirements for correction and corrective action.
Join industry expert, Susanne Manz from Manz Consulting to learn the essentials of dealing with non-conforming material and performing effective failure investigations.
Who should attend?
- 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
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 .
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.