This webinar will discuss in detail the use of the Global Harmonization Task Forces (GHTF) and Notified Body Operations Group (NBOG) supplier guidance documents to create QA agreements.
Attendees will learn best practices to ensure compliance with FDA and EU guidelines for supplier quality agreements.
Why Should You Attend:
Detailed supplier Quality Assurance (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 of product and service suppliers. Supplier QA agreements can be an important part of demonstrating this control. In addition, the operations group for European Notified Bodies (NBOG) released a guidance document in 2010 outlining how your ISO 13485 auditors should audit you.
This webinar will provide an understanding of what the current guidance documents suggest be included in supplier agreements. 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 how you are doing this control as part of your supplier management program. 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 by demonstrating that you have sufficient control of your key suppliers.
LearningObjectives
- To learn why QA agreements are necessary and desirable
- To review which suppliers need QA agreements
- To understand contents of supplier QA agreements
Areas Covered
- Types of suppliers that should have QA agreements to ensure FDA and ISO 13485 compliance
- Explanation and use of the Global Harmonization Task Forces (GHTF) and NBOG supplier guidance documents to create QA agreements
- How to create supplier QA agreements and the best way to implement them
- Definition of and requirements for critical suppliers
- Supplier agreements best practices
Instructor
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 for both FDA and ISO 13485 compliance band business when they became FDA and industry requirements. Her are areas of expertise include training, auditing, supplier management, design controls, software validation and general safety.
Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections.
She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the RAPS, 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.