Risk-based Supplier Control: How to Meet FDA and your ISO 13485 Notified Body’s Expectations and Reduce your Own Risk

This 90-minute webinar will provide you the information you need to assure your supplier management program is in compliance with the latest European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.

Why Should You Attend:

You depend on your suppliers, but can your system prove that you have sufficient control over, especially, your critical suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements?

Areas Covered in the Seminar:

• The types of suppliers that must be qualified according to the FDA and ISO 13485.
• Explanation, and use of the Global harmonization Task Force s(GHTF) and NBOC supplier guidance documents that you could be audited to.
• How to create or bring your supplier program into compliance with the these guidance documents.
• Definition of and requirements for Critical suppliers.
• Defining and controlling supplier risk and why this benefits you.
• Supplier qualification and control, best practices.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in

• Quality Management
• Regulatory Affairs
• Supply-chain Management
• Supplier engineering