Risk-based Supplier Control: How to Meet FDA and your ISO 13485 Notified Body's Expectations and Reduce your Own Risk

Instructor: Betty Lane
Product ID: 702501
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This 90-minute webinar 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 potentially reducing your cost of compliance.

Course "Risk-based Supplier Control: How to Meet FDA and your ISO 13485 Notified Body's Expectations and Reduce your Own Risk" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

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?

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.

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 supplies 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.

Learning Objectives:

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.
  • 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.

Areas Covered in the Seminar:

  • 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.

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

Instructor Profile:

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.

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