The FDA and notified bodies cannot hold your suppliers to the quality system regulations, so they expect you to control those suppliers yourself, especially the critical ones. This supplier management webinar explains how to build a program that meets those expectations.

You'll review QSR and ISO requirements for supplier evaluation, including which types of suppliers need to be evaluated, how to define critical suppliers and how to handle outsourced processes. The requirements for supplier assessment are covered as well.

The session also looks at quality agreements, documentation and how to apply a risk-based process so your supplier management system fits your company instead of becoming a burden.

WHY SHOULD YOU ATTEND?

You rely on suppliers for goods and services, but can your system prove to auditors and regulators that you control them well enough to keep your product safe? A compliant program can still be costly if overhead runs out of control, and being too demanding can alienate or even lose suppliers.

This session suits regulated companies that want a compliant, cost-efficient program, including supply chain, purchasing, buyers, CAPA coordinators, regulatory, QA and executive management, and internal auditors.

AREA COVERED

Supplier selection

• Review of FDA and ISO requirements
• Types of suppliers that must be qualified
• Defining critical suppliers
• Classifying 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

LEARNING OBJECTIVES

• Apply QSR requirements for supplier evaluation and assessment
• Apply ISO requirements for supplier evaluation and assessment
• Define supplier types and identify which require evaluation
• Use best practices for critical suppliers and outsourced processes
• Apply a risk-based process to build a customized supplier management system

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