ComplianceOnline

Integrating Risk Management with the Quality System

Instructor: Edwin L Bills
Product ID: 701039
  • Duration: 90 Min

recorded version

$149.00
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: Dec-2008

Training CD

$350.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

The purpose is to assure that the medical product is designed, manufactured, and distributed in such a manner that the customer receives the safest possible product.

Description

This webinar will provide guidance to those responsible for implementation of risk management processes in medical product companies.

Risk Management is intended to be a component of an overall Quality System during all phases of the lifecycle of a medical product. The purpose is to assure that the medical product is designed, manufactured, and distributed in such a manner that the customer receives the safest possible product. Risk Management recognizes that there is always some degree of risk in the use of a medical product, but the complete and successful integration of risk management in the quality system will result in a low risk product being delivered for use.

Areas Covered in the seminar:

  • Previously, companies have considered risk in the design of medical devices through the use of FMEA, but have often failed to completely integrate the results of the risk process in the manufacturing and delivery process, and especially in the post-market phases, such as CAPA.
  • Risk management throughout the quality system, including design, manufacturing, distribution and post-distribution.
  • Successful application of risk management principles within quality procedures.

Who will benefit:

This webinar will provide guidance to those responsible for implementation of risk management processes in medical product companies. It will be helpful to those who are responsible for the quality system procedures and those who are responsible for the risk management process as well.

  • Quality System Management Representatives
  • Quality Managers
  • Risk Managers
  • Other persons with risk management responsibities

Instructor Profile:

Edwin L. Bills, was Industry Co-chair for the AAMI Committee AAMI/QM/WG 04 Application of risk management to medical devices, representing the United States on ISO TC 210 Joint Working Group 1 which developed the ISO 14971 standard. He has served as a Director of Risk Management for major medical device companies. Mr. Bills also presented at a number of conferences on Risk Management topics and has authored articles on the topic as well.

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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.

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.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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