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Creating a Risk-based Supplier Management Program

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Online Webinar by  Online Compliance Panel
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Online / Webinar
Ended last May 14, 2018
USD  250.00 (VAT incl.)

Details

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.

Objectives of the Presentation
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 13485:2016, 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
Why Should you Attend
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.

Areas Covered
  • 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
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.

Schedules

May 14, 2018
ENDED
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Onlinecompliancepanel is a dedicated team of youngsters, who work in tandem with the latest US FDA regulations/regulatory compliance in creating training sessions suitable for individuals and corporations. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Our interactive training sessions could be beneficial to corporations thriving in industries such as pharmaceuticals, drugs and chemicals, FDA compliance, medical devices, packaging and labeling, food and beverages, banking and finance, audits and inspections, recalls and crisis management and many more. We emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices, risk management and market trends.

Professional training, in the essential quality disciplines, contributes to both the competitiveness of your business and also to personal motivation; it broadens the experience and accelerates the development of those who participate. We provide training in a number of ways: ...
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