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:
- To learn why QA agreements are necessary or desired
- Define types of Key suppliers
- To define and discuss which supplier must have QA agreements
- Examine how Risk Management and Supplier QA agreements are related
- To know what should be in QA agreements
- To look at the content different types of QA agreements for different types of suppliers
- Discuss implementing QA Agreements and best practices
Areas Covered:
- What are Supplier QA Agreements
- QA Agreements vs Supply Agreements
- What are FDA and ISO 13485 requirements for Supplier Agreements
- Types of Key Suppliers
- Definition of and requirements for Critical suppliers
- Outsourced processes and their suppliers
- The types of suppliers that should have QA Agreements to assure FDA and ISO 13485 compliance
- Explanation, and use of the Global harmonization Task Force s (GHTF) and NBOC supplier guidance documents to create QA agreements
- Risk Management and QA Agreements
- How to create supplier QA agreements
- What should be in a supplier QA Agreement
- Manufacturing QA agreements
- Outsourced Processes QA agreements
- Distributor QA agreements
- QA Agreements for other types of suppliers
- Ways of implementing QA agreements
- Supplier agreements best practices
Who will Benefit:
- Quality Managers and Directors
- Quality systems associates and specialists
- Supplier quality engineers
- Internal auditors
- Supplier auditors
- Regulatory Affairs Compliance managers and associates
- Supply-chain Managers
- Supplier engineers
- Purchasing Managers
- Consultants to medical device companies
- Operations managers and directors
- 08:30 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
- 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
Betty Lane
Founder and President of Be Quality Associates, LLC
Betty Lane has over 30 years’ experience in medical device quality assurance and regulatory affairs. She is the founder and president of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well as managing quality system requirements in other locations such as Europe and Canada. Her background in digital systems engineering enables her to facilitate compliance with design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
Ms. Lane’s training experience includes over 25 years of training on all areas of ISO 13485 and FDA cGMP in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs at Northeastern University, Boston, MA. Ms. Lane is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute, and an MBA from Northeastern University.
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