ComplianceOnline

Supplier Management for FDA Compliance

Instructor: Jeff Kasoff
Product ID: 700193
  • Duration: 60 Min

recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance.

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 Webinar:

  • QSR and ISO 13485 requirements for supplier selection and assessment.
  • How to qualify new suppliers in a cost efficient manner.
  • How to assess current suppliers in a cost efficient manner.
  • How to perform supplier-related corrective action.
  • Minimum documentation requirements 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:

  • Purchasing management
  • Regulatory management
  • QA management
  • Consultants

Instructor Profile:

Jeff Kasoff, RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Mr. Kasoff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For 13 years prior to that, he served as director of regulatory affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Mr. Kasoff 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. He received his Regulatory Affairs Certification in 1996.

Topic Background:

A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot 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 a procedure in place that describes 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 never have to pay a visit to your supplier if you have a good supplier control program in place.

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