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Non-Conforming Material and Failure Investigation

From Wednesday, July, 18, 2018 to Wednesday, July, 18, 2018 in ca
Starting from:10:00

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
    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.

Event link :
Contact Details:
NetZealous LLC, DBA compliance4All
Phone: +1-800-447-9407
Accreditations: 0
Concerned Public:
Attendance: International
Visitors/Participants: n.c
Speakers: n.c
Exhibitor: n.c
Event Type: Online Conference
Major Sector: BIOMEDICAL
Concerned sectors: Biomedical -Medical and Hospital Management -

161 Mission Falls Lane, Suite 216,
94539 Fremont

Congress, conferences or medical training REF #28-8101
Non-Conforming Material and Failure Investigation
Published on on:2018-05-29 11:43:26
Congress, conferences or medical training in BIOMEDICAL
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