Selecting and Managing Device Suppliers - Webinar CD/Transcript

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Selecting and Managing Device Suppliers: Proven Techniques to Comply With FDA QSR and ISO 13485 Requirements

Poorly designed and executed supplier audits are costing devicemakers millions — and run the risk of 483s and warning letters.  With dozens, hundreds or even thousands of suppliers to manage, you need a proven risk-based process that meets FDA and ISO requirments.

Devicemakers: Your patients, products and reputation rely on how you conduct supplier audits.

Fail to properly conduct supplier audits and lawsuits and liability are sure to follow, not to mention 483s and warning letters.

Looking for a proven solution that can reduce the number of audits you conduct?  Or how about not having to audit some suppliers ever again?

With compliance pro Jeff Kasoff as your guide, you’ll master developing a bulletproof supplier controls program that assures quality products and flawless inspections. Order Jeff’s webinar CD and transcript to show you the way.

Jeff’s job is overseeing supplier qualification and assessment, including reviewing potential suppliers and evaluating their performance.  He lives and breathes this stuff every day.  And he’s on the front lines during FDA and ISO inspections.

In addition to a wealth of knowledge and best practices, you receive these special bonuses:

  • Verbatim sections of a proven supplier agreement
  • Sample SCAR (Supplier Corrective Action Request) form that has been reviewed as part of many successful FDA inspections

Get set for a fast-paced 90-minute learning experience. Mr. Kasoff covers a lot of ground:

  • Latest interpretation of QSR and ISO 13485 requirements for supplier selection and assessment by the FDA and EU investigators
  • How to sign on and qualify new suppliers cost-effectively
  • Innovative, economical assessment techniques for current suppliers — even when they number in the thousands
  • What to do when your supplier fails. How to use SCAR forms and explain them to investigators during audits
  • Minimum documentation for supplier qualification, assessment, and related corrective action — are you even prepared to meet this low bar
  • And much more

FDA and EU inspections are turning up countless supplier controls violations. Why risk a Form 483, warning letter or lawsuit? A cost-effective supplier controls program assures quality products and safe patients. Besides, it’s just good business.

  • Supplier management professionals
  • Supply chain professionals
  • QA/QC personnel
  • Manufacturing directors and supervisors
  • Regulatory/legislative affairs professionals
  • Risk management specialists

Jeff Kasoff, RAC, CQM, is Director-Quality at Medivators, a leading maker of endoscopy consumables and instrumentation. He previously served as Director of Regulatory Affairs at Life-Tech Inc., where he introduced and implemented a supplier management system. Prior to that, as Optex Biomedical’s first full-time employee, he initiated that devicemaker’s regulatory policies and procedures and prepared its submissions.