2014 - Supplier Quality Agreements ? Essential for Suppliers of many outsourced processes

Instructor: Betty Lane
Description:
Detailed supplier QA agreements with key suppliers, whether standalone or part of a larger supplier agreement, are becoming essential as more medical device companies are looking to increase their outsourcing.
Both ISO 13485 European Notified Bodies and the FDA are requiring companies to create detailed agreements with their key suppliers. The 2008 GHTF supplier guidance document is now an expectation of both the FDA and most ISO 13485 auditors. These auditors must verify that you have objective evidence of control or product and service suppliers. Supplier QA agreements can be an important part of demonstrating this control.
This webinar on supplier quality assurance (QA) agreement will provide you the information on how to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485 Notified Body auditors.
Why Should you Attend:
This presentation will provide an understanding of what the current guidance documents suggest you include in supplier agreements. Quality Assurance (QA) agreements are usually more flexible than standard supplier agreements and can therefore be more detailed and easier to modify than standard supplier contracts which often require legal, as well as management approval. QA agreements with you suppliers can be the easiest way to assure both your company and auditors that you have sufficient control of your key and critical suppliers. QA agreements give details of who is responsible for what between you and your supplier. Yet, because these agreements are detailed and specific to a particular supplier, they should only be used for those suppliers where they provide value. Even if your key suppliers are only from different branches of your own company, a supplier QA agreement can be an important tool to show the FDA and ISO 13485 Notified Body auditors that you have the required control of these suppliers.
In addition to defining the content of a supplier agreement, this presentation will help you decide who needs these agreements and how best to implement them. Supplier control has always been an FDA and ISO 13485 requirement, but the current expectation is that you actually document this control as part of your supplier management program, and QA agreements can be an easy way to demonstrate this control for key or critical suppliers.
This presentation will help you prepare for the current expectations of FDA and ISO 13485 notified bodies for demonstrating that you have sufficient control of your key suppliers.
Objectives of the Presentation:
To understand the types of suppliers that should have QA Agreements to assure FDA and ISO 13485 compliance
To understand the basics of the Global harmonization Task Force s (GHTF) and NBOC supplier guidance documents to create QA agreements
To learn why QA agreements are necessary and desirable
Learn how to create supplier QA agreements and the best way to implement them
Learn some Supplier agreements best practices
Who can Benefit:
This webinar will provide valuable assistance to all personnel in:
Quality Management
Regulatory Affairs
Supply-Chain Management
Supplier Engineering
Purchasing Management
Supplier auditing
Register Now:
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