Webinar Duration: 90 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Susanne Manz
OVERVIEW:
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
SPEAKER PROFILE:
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, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne 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.
