Why Should You Attend:
ISO 14971:2007 is the de facto standard for medical device risk management. It requires more than just Risk Assessment or an FMEA. ISO 14971:2007 is the de facto standard for medical device risk management. It requires more than just Risk Assessment or an FMEA. Your Risk Management program should be able to answer these questions easily. If not, then your team needs to attend.
This course provides the attendees with an overview of ISO 14971:2007 and implementation tips for an effective system for managing risk. We provide an overview using flow charts that shows each of the elements of a Risk Management system and how they fit together. This approach helps the participant understand the essential structure and the required elements.
We will look at the elements of Risk Management, including the required documents. This includes: A risk management plan, risk evaluation documentation, risk verification activities, risk management report, risk management file, obtaining production information and linking complaints to provide post-production information.
You will learn when written procedures are required, when (and how) to name designated individuals, when (and how) to formally designate units, and the records you must keep.
Areas Covered in the Seminar:
Who will Benefit:
This seminar is for quality, regulatory, production, and design people who may become involved in risk analysis or Risk Management. Because risk management is a life cycle approach, sales and service people may also become involved.
Attendees should understand design and manufacturing processes. Knowledge of complaint handling procedures and corrective action procedures is useful.
Because of the cross functional and cross discipline aspects, this is an ideal opportunity for team attendance. You need to ensure that all parties get the same message. People in the following roles can especially benefit from the knowledge in this webinar:
Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and holds an APICS certification in Resource Management.
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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).
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