ComplianceOnline

Creating a Risk-based Supplier Management program

Instructor: Betty Lane
Product ID: 702501
  • Duration: 75 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Feb-2017

Training CD

$349.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, 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.

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?

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.

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 Webinar:

  • 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

Betty Lane
Founder and President, Be Quality Associates LLC

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.

Topic Background:

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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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