Non-Conforming Material and Failure Investigation
In this webinar, we will discuss the requirements for successfully managing non-conforming material and conducting failure investigations, and requirements for correction and corrective action, also learn the essentials of dealing with non-conforming material.
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 how to identify, segregate, control, and disposition non-conforming material. You'll learn about conducting failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting Inc, to learn the essentials of dealing with non-conforming material.
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.
Areas Covered in the Session:
- Overview of the Regulations
- Definitions and Expectations
- Segregation and Control
- Disposition of NC material
- Concessions
- Acceptance Activities
- Failure Investigation
- Correction and Corrective Action
- Documentation Requirements and Records
- Lessons Learned and Common Mistakes
- Preparing for an FDA Inspection
Learning Objectives:
- FDA Expectations
- Non-conforming Material
- Documentation Requirements
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
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.