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 meet 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 folks!
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. Also covered will be a discussion of supplier nonconformance, including how and when to issue the dreaded Supplier Corrective Action Request.
Areas Covered in the Session :
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
Documentation requirements
Supplier Nonconformance: Supplier Corrective Action Requests
Pre-notification?
Best Practices for Issuance
Evaluation/Acceptance of Supplier Response
Tracking effectiveness
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