Best Practices for Lean Supplier Management in Compliance with FDA and ISO 13485 Requirements

Duration: 60 Minutes
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.
FDA and ISO 13485 Requirements
Instructor: Jeff Kasoff
Product ID: 505073
Objectives of the Presentation
Supplier Selection
  • Review of FDA and ISO requirements
  • Types of suppliers that must be qualified
  • Defining critical suppliers
  • Outsourced processes
  • Recommended Practices
Supplier Assessment
  • Review of FDA and ISO requirements
  • Recommended practices
  • Justification of desktop audits
  • Documentation requirements
Why Should you Attend
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 and system 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!

This webinar will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation, including "critical" suppliers and outsourced processes. The QSR and ISO requirements for supplier assessment will be defined as well.

Who will Benefit
This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:
  • Supply chain management
  • Buyers
  • Purchasing management
  • CAPA Coordinators
  • Regulatory management
  • QA management
  • Executive management
  • Internal auditors
  • Regulatory personnel
  • Quality Engineering personnel
  • Sales and Marketing personnel
  • Customer Service personnel
  • R&D personnel
  • Manufacturing Engineering
  • Consultants
  • Quality system auditors
$375
Recorded Session for one participant
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Live Session - How it works
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup 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 has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.
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