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

OVERVIEW

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!

WHY SHOULD YOU ATTEND

This class 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

• 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

LEARNING OBJECTIVES

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

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

SPEAKER

Jeff Kasoff, RAC, CMQ/OE, LBB, 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 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. 

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