6Hrs Virtual Seminar: Supplier Management for Medical Device Manufacturers: How to Meet FDA and your ISO 13485 Notified Body's Expectations and Reduce your Own Risk

Jeff Kasoff

Starting at

$1099


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Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

  • How well do you understand the requirements for supplier management?
  • Could you pass a regulatory audit or inspection without any issues?

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the supplier’s location, supplier auditing techniques, and supplier issues in management review.

The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.

In addition to the discussion material, the course includes multiple exercises, guidance documents, and templates/tools to help you implement an effective program

Learning Objective:

Upon course completion, participants will:

  • Understand FDA QSR and ISO 13485 requirements for supplier management
  • Understand the FDA’s multi-tier supplier classification system
  • Understand when suppliers have to register and list with the FDA
  • Use an analysis matrix and radar chart to compare suppliers
  • Explain the link between design control and purchasing data
  • Develop an overall supplier management plan
  • Understand how to develop and implement supplier controls
  • Create receiving inspection criteria and apply them as part of supplier controls
  • Create supplier measurement and monitoring systems
  • Create a system for supplier business risk
  • Create a system for supplier regulatory risk
  • Create a risk based system for supplier audits
  • Develop a supplier audit using the backward trace process approach

Who will Benefit:

  • Quality Managers
  • Supply Chain Managers
  • Quality Engineers
  • Supplier Quality Engineers
  • Purchasing Professionals
  • Regulatory Specialists
  • Production and Process Engineers
  • Design and Development Engineers
  • Verification and Validation Specialists
Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Jeff Kasoff,

Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.


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