Training Course Syllabus:

Course 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 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 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 outside 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 and looking at specific examples, this presentation will help you decide how best to implement these agreements in your company. 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 seminar on supplier quality assurance (QA) agreement will provide you the information you need to create supplier quality agreements (QA Agreements) with your key suppliers. This includes understanding which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485 Notified Body auditors.

Learning Objectives:

Areas Covered:

DAY 01(8:30 AM - 4:30 PM)

Registration Process - (8:30 AM till 9:00 AM)
Session will begin by – (9:00 AM)
09:00 AM – 09:00 AM Registration and Meet & Greet
09:00 AM – 9:30 AM
Seminar objectives review, expectations and scope.
Introductions
09:30 AM – 10:30 AM
What are Supplier QA Agreements
QA Agreements vs Supply Agreements
What are FDA and ISO 13485 requirements for Supplier Agreements
Definition of and requirements for Key suppliers and Critical suppliers
Outsourced processes and their supplier
10:30 AM – 10:45 AM Break
10:45 AM – 12:00 PM
The types of suppliers that should have QA Agreements
Applicable Guidance documents and their use
Risk Management and QA Agreements
12:00 PM – 1:00 PM Lunch
1:00 PM – 2:45 PM
What should be in a supplier QA Agreement
How to create supplier QA agreements
Manufacturing QA agreements content and examples
2:45 PM – 3:00 PM Break
3:00 PM – 3:45 PM Outsourced Processes QA agreements content and examples
3:45 PM – 4:30 PM Distributor QA agreements content and example

DAY 02(8:30 AM - 1:00 PM)

08:30 AM – 09:00 AM Registration and Meet & Greet
09:00 AM – 9:30 AM
Seminar objectives review, expectations and scope.
Questions and Answers from Day 1
9:30 AM - 10:30 AM QA Agreements for other types of suppliers content and example
10:30 AM - 12:00 PM
Ways of implementing QA agreements
Supplier agreements best practices
Final Questions and Answers
12:00 PM – 01:00 PM Lunch

Seminar Summary:

This presentation will provide an understanding of what the current guidance documents suggest you include in supplier agreements. (see full course description)

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