Supplier Evaluation and Assessment: How to Meet FDA QSR and ISO 13485 Requirements in a Cost-Effective Manner


  Duration: 60 Minutes  

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Jeff Kasoff   Product Id : 501264
  Instructor : Jeff Kasoff

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Overview:

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain 'approved.' You may never have to pay a visit to your supplier if you have a good supplier control program in place.

Why should you Attend: Supplier qualification and assessment is required according to both QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance with this. Organizations can, however, spend much less time and money, and still be in control of their suppliers and in compliance with the regulations. This presentation will review the QSR and ISO requirements for supplier evaluation and assessment. It will also provide cost efficient and equally compliant options for many of the most common practices in supplier management programs.

Areas Covered in the Session:

  • QSR and ISO requirements for supplier selection
  • QSR and ISO requirements for supplier assessment
  • Recommended processes for new supplier qualification in a cost efficient manner
  • Recommended processes for current supplier assessment in a cost efficient manner
  • Supplier-related corrective action: Practices, Documentation, and Follow-up
  • Implementation of a lean system for supplier qualification, assessment, and related corrective action

Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that are interested in implementing a supplier management program that is
both compliant and cost-efficient. The employees who will benefit include:
  • Supply chain management
  • Purchasing management
  • Regulatory management
  • QA management
  • Executive Management


Speaker Profile
Jeff Kasoff , RAC, CMQ/OE is the Principal Consultant at Lean to Quality, LLC. He s has more than 30 years of experience in Quality and Regulatory management. Over that time, He has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE




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