Integrating Risk Management with the Quality System
Instructor:
Edwin L Bills
Product ID: 701039
- Duration: 90 Min
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
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.
More Training By Experts
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).
