Supplier Quality Agreements - Essential for Suppliers of Outsourced Processes Webinar Time: 11:30 AM PST, 02:30 PM EST
Duration: 90 Minutes
Instructor: Susan Fahey Desmond
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. This presentation will also 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.
Why Should you Attend
This presentation will provide an understanding of what the current guidance documents suggest you to 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 your 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.
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