2014 - Creating a Risk-based Supplier Management program

Instructor: Betty Lane
Description:
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while using risk information so you may reduce your cost of compliance.
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 documentation expectations in the areas of risk and supplier control that you must be aware of and implement, which this seminar will explain how to implement. 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
Understand 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
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.
Why Should you Attend:
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 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?
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 new documentation expectations in the areas of risk and supplier control that you must be aware of and implement, 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.
Objectives of the Presentation:
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
Understand requirements for Critical suppliers
Understand how to define and control supplier risk and why this benefits you
Learn about best practices for supplier qualification and control
Who can 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
Quality engineering
Register Now:
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