In this webinar you will learn how to create detailed quality agreements (QA Agreements) for key suppliers, particularly those for outsourced processes, and to understand which of your suppliers should have these agreements to meet the expectations of the FDA and ISO 13485:2016 and MDSAP. The agreements discussed will meet the expectations of the GHTF and NBOG supplier guidance documents which are now an expectation of both the FDA and most ISO 13485 auditors. These supplier QA agreements can be an important part of demonstrating that you have control of your key suppliers.
Why Should You Attend:
This presentation will provide an understanding of what the current guidance documents suggest you include in supplier agreements for several types of key suppliers. 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 and those who supply outsourced processes. 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.Areas Covered in the Webinar:
- The types of suppliers that should have QA Agreements to assure FDA and ISO 13485:2016 compliance
- Explanation, and use of the Global harmonization Task Force s (GHTF) and NBOC 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
- Suppliers of outsourced processes
- Supplier agreements best practices
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:- Quality Management
- Regulatory Affairs
- Supply-chain Management
- Supplier Engineering
- Purchasing Management
- Supplier Auditing
- Internal Auditing
- Consultants to Medical Device Companies
Course Provider
Betty Lane,
