Objectives of the Presentation
This webinar will provide valuable assistance in:
Why Should you Attend
- Developing or updating your supplier control system to one based on risk
- Complying with ever more stringent expectation of ISO 13485:2016, FDA and MDSAP auditors related to suppliers
- Understand the special requirements related to contract manufacturers, distributors, critical suppliers and suppliers of outsourced processes
- Determine different ways to assess suppliers based upon risk
- Learn the importance of developing solid contractual agreements with key suppliers
- Understand the importance of supplier quality and its relevance to ISO 13485 and FDA's quality system requirements
This presentation will provide an understanding of the two important guidelines now being used by FDA and ISO 13485 Notified Body auditors. This will allow you to make sure your supplier management and control system meets these guidelines, especially for outsourced processes including contract manufacturing, distribution, sterilization and testing. You depend on your suppliers, but can your system prove that you have sufficient control over especially your critical suppliers, to assure auditors and regulatory agencies that your product is safe and meets all your requirements?
In addition to defining the content of a supplier management program, the guidance documents require that you understand, define, document and control the risks related to all of your suppliers. This may include some of the suppliers of your suppliers. 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 most supplier control programs have not done this in the past.
As regulatory bodies are getting more pressure on them from governments and the general public, they have to use the tools of auditing quality management systems to make sure that manufacturers' are producing safe and effective medical devices. Since particularly the FDA, cannot require your suppliers to meet the same quality system regulations that you do, they must do as much as they can to make sure you are exercising sufficient control over your suppliers. This presentation will help you prepare for the current expectations for evaluating and controlling your suppliers.
Who will Benefit
- The types of suppliers that must be qualified according to the FDA and ISO 13485
- Explanation, and use of the Global Harmonization Task Force s(GHTF) and NBOC supplier guidance documents that you could be audited to
- How to create or bring your supplier program into compliance with the these guidance documents
- Definition of and requirements for critical suppliers
- Defining and controlling supplier risk and why this benefits you
- Supplier qualification and control, best practices
This webinar will provide valuable assistance to all personnel in
- Quality Management
- Regulatory Affairs
- Supply-chain Management
- Supplier engineering
- Purchasing Management
- Supplier auditing
As more virtual companies come into existence and most medical device companies are looking to increase their outsourcing, both ISO 13485 European Notified Bodies and the FDA are putting more pressure on companies to do an increasingly more rigorous job of controlling their suppliers. Following the GHTF supplier guidance document is now an expectation of both the FDA and most ISO 13485 auditors. In addition the operations group for European notified bodies (NBOG) released a guidance document outlining how your ISO 13485 auditors should be auditing you.