Control of Products and Services Obtained from Suppliers

Instructor: Edwin L Bills
Product ID: 701379
Training Level: Intermediate
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2009

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This Supplier control webinar will explore the regulatory requirements for supplier controls by medical device manufacturers and will review the recommendations by the GHTF for manufacturers of medical devices.

Why should you Attend:
The US FDA has discovered that a reasonably large number of recalls and adverse events are related to supply product. Medical device supplier activities are now a focus area for FDA inspections and also third party audits. This concern is now reflected internationally with the publication of a GHTF guidance document on supplier activities. This increased focus by regulators on supplier activities should cause medical device companies to review their processes against requirements to avoid audit and inspection findings.

This presentation will explore the regulatory requirements for supplier controls by medical device manufacturers. It will review the recommendations by the GHTF for manufacturers of medical devices. The presentation will also review best practices in supplier controls and how to meet new expectations of regulators in supplier management. Implementation of a compliant Supplier Management system will lead to lower cost by working with suppliers in key areas to reduce supply chain problems.

Areas Covered in the seminar:

  • Supplier Controls reduce supplier problems.
  • Supplier evaluation techniques lead to selection of better suppliers.
  • Supplier selection processes must be effective in choosing the right suppliers.
  • Acceptable Supplier Listings are used to show what products suppliers can efficiently provide.
  • Removing suppliers from Acceptable Lists when there are issues.
  • Impact of Risk Management on Supplier processes.
  • How to develop a Supplier Management process that meets regulators expectations.
  • Supplier contracts must have several key elements to meet regulatory requirements.

Who will benefit:

This presentation will help those responsible for supplier activities, including those from purchasing organizations, quality organizations and also those in design groups that interface with suppliers and design purchased components and products. Selecting the right supplier and providing the proper interface between supplier and customer can reduce costs and improve responsiveness.

  • Purchasing Managers
  • Purchasing Agents
  • Supplier Quality Engineers
  • Design Engineers
  • Quality Managers
  • Engineering Managers

Instructor Profile:
Edwin L. Bills, is the Principal Consultant for Bilanx Consulting LLC, a consulting firm that provides assistance to medical device companies in compliance with US FDA regulations, in development of Quality Management Systems and Risk Management processes. Edwin has over 20 years experience in the medical device industry and has participated in development of industry standards, including ISO 14971. In his consulting role he has assisted companies in Warning Letter responses. Edwin has also participated in training both company and FDA personnel in the Quality System Regulation and Product Risk Management.

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Medical Device Summit 2018

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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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