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 2008 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 in 2010 outlining how your ISO 13485 auditors should be auditing you.
This presentation will provide an understanding of the two important guidelines now being use by FDA and ISO 13485 Notified Body auditors. This will allow you to make sure your supplier management and control system meet these guidelines,especially for outsourced processes such as contract manufacturing,distribution, sterilization and testing. This will assure that you can meet regulatory requirements while having a cost effective supplier management program that fits with you operational goals. You depend on your suppliers, but can your system prove that you have sufficient control over your suppliers,especially your critical suppliers, to assure auditors and regulatory agencies that your product is safe and meets all your requirements?
If you understand, define, document and control the risks related to all of your suppliers, as the guidelines require, you will make your supplier management program more cost effective. There are specific documentation expectations in the areas of risk and supplier control that you must be aware of and use, which this seminar will explain how to implement.
Remember Notified bodies and the FDA, cannot require your suppliers to meet the same quality system regulations that you do, so they must make sure you are exercising sufficient control over those suppliers.
Understand the types of suppliers that must be qualified according to the FDA and ISO 13485
Learn about the two guidelines that cover current FDA and ISO 13485 expectations for supplier control
Understand how to use of the Global harmonization Task Force s(GHTF) and NBOC supplier guidance documents that you could be audited to
Understand how to create or bring your supplier program into compliance with the these guidance documents while optimizing the resources needed to comply
Understand requirements for Critical suppliers
Understand how to define and control supplier risk and why this benefits your company
Learn about best practices for supplier qualification and control
This webinar will provide valuable assistance in:
Developing or updating your supplier control system to one based on risk
Complying with ever more stringent expectation of ISO 13485 auditors related to suppliers
How a risk-based system not only meets regulatory expectation, but can potentially reduce your cost of regulatory compliance
Understanding the special requirements related to contract manufacturers, distributors, and other critical suppliers
Determining different ways to assess suppliers based upon risk
Learning the importance of developing solid contractual agreements with key suppliers
Understanding the importance of supplier quality and its relevance to ISO 13485 and FDA’s quality system requirements
When might your supplier be subject to an unannounced audit by your notified body
Duration: 75 Minutes
Group of 3 to 5
Group of 6 to 10 + DVD-USB
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session