Supplier Management: How to meet FDA QSR and ISO 13485 Requirements in a Cost Effective Manner
  • CODE : JEKA-0023
  • Duration : 60 Minutes
  • Level : Intermediate
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Jeff Kasoff, RAC, CMQ/OE has more than 30 years of experience 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 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 the 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. He is also a certified internal auditor for MDSAP, ISO 13485:2016, and EU MDR, from Exemplar Global.

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 the system meet all required regulations, especially for critical suppliers.

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. The webinar will discuss the application of a risk-based process resulting in a customized supplier management system.

Areas Covered

Supplier Selection

  • Review of FDA and ISO requirements
  • Types of suppliers that must be qualified
  • Defining critical suppliers
  • Classification of suppliers
  • Outsourced processes
  • The Quality Agreement
  • Recommended Practices

Supplier Assessment

  • Review of FDA and ISO requirements
  • Recommended Practices
  • How to avoid “Death by Supplier Audit”
  • Documentation requirements

Course Level - Intermediate

Who Should Attend

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

Why Should You Attend

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!

  • $179.00



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