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Medical Devices Compliance

Supplier Management and Corrective and Preventive Action in FDA- and ISO-regulated Industry

Summary

This in-person seminar will cover two areas that are critical for compliance: Supplier Management and CAPA.

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management subsystem meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them – try explaining that to your supply chain management!

Areas Covered in the Session

Supplier Management

  • Regulatory Requirements
  • Supplier Qualification
  • Utilizing the Quality Agreement
  • Supplier Assessment
  • Supplier Nonconformance

CAPA

  • Understanding CAPA
  • Elements of a CAPA Program
  • Root Cause: A Primer
  • How FDA Trains Its Investigators for CAPA, and Best Practices for Preparation

Jeff Kasoff

Expert

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 similary 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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