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
FDA Faculty Susanne Manz

Susanne Manz (25+ years exp.)

Consultant | Educator | Author

Baltimore, Maryland Area

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.  

Choose a Purchase Option


$299

Recorded Access Corporate Group

You'll have access to group log-in for an archived recording of the entire 90-minute webinar, including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$899

Purchase Using Webinar All-Access Pass

(One user get unlimited access to all upcoming and recorded webinars (350+) for one year)

Our Participants Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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