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Non-conforming Materials in a Medical Device Company – dealing with in-house to field issues

Location: California, USA
From: 2021/04/08 10:30
To: 2021/04/09 12:00
Posted by: WCS Compliance

About this Event

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

Webinar 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 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.

Webinar Takeaway

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
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
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.

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
For Registration Click Below Link


Susanne Manz (25+ years exp.)

Consultant | Educator | Author

Baltimore, Maryland Are

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 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 is a certified Master Black Belt in Six Sigma. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality.

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