Supplier Management in FDA- and ISO-regulated Industry

Supplier Selection
Review of FDA requirements
Review of ISO requirements
Types of suppliers that must be qualified
Defining critical suppliers
Outsourced processes
Recommended Practices
Documentation requirements
Use of Risk Assessment
The Quality Agreement
Common Pitfalls

Supplier Assessment
Review of FDA requirements
Review of ISO requirements
Case Study: A Hypothetical Supplier Assessment
Recommended Practices
Documentation requirements
Use of Risk Assessment
Common Pitfalls

Supplier Nonconformance
Types of supplier nonconformances
Best Practices for Notification
Best Practices for Handling
Trending
Evaluation of Supplier Response
Tracking effectiveness
Supplier Corrective Action Requests
Pre-notification?
Best Practices for Issuance
Followup
Evaluation/Acceptance of Supplier Response
Tracking effectiveness

Workshop: Review of Supplier Responses: Acceptable or UNacceptable?

This seminar 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

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. The QSR/ISO requirements for supplier assessment will be defined as well. Attention will be paid to inclusion of risk management in across both supplier qualification and assessment, implementation of which will allow your company to devote value-added resources to these efforts. Significant time will be spent on discussion of the topic of supplier nonconformance, including how and when to issue the dreaded Supplier Corrective Action Request. Your supplier nonconformance handling process must be nonconfrontational, or even better, collaborative. 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 folks.