ComplianceOnline

Risk Management Activities during Design Input

Instructor: Edwin L Bills
Product ID: 700526
  • Duration: 60 Min

recorded version

$149.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2007

Training CD

$250.00
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CD and Ref. material will be shipped within 15 business days

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Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation.

Description

Risk Management Activities can lead to reduced cost and reduced time to market when conducted during the Design Input phase of product development. Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation.

Find out about data sources that can be mined to reduce risks early in the design process thus giving developers more information to aid in product design.

Areas Covered in the seminar:

  • Preliminary Hazard Analysis a tool for improved product design.

Who Will Benefit:

This webinar will update personnel at medical device companies on the new standard and point them to the additional information available in the newly revised document. The information will assist in meeting various national and global regulatory requirements for medical devices.

  • Design personnel using risk management during development of new medical devices.
  • Quality managers responsible for integrating risk management into quality systems.
  • Regulatory and compliance personnel who develop premarket filings and technical files for medical devices.
  • Personnel responsible for verification and validation activities.
  • Quality system auditors.

Instructor Profile:

Edwin L. Bills, has over 20 years experience in the field of quality and regulatory affairs. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of the committee. In this position he represented the United States on the ISO/IEC Joint Working Group on risk management for medical devices, the group responsible for authoring ISO 14971, the medical device risk management standard. He also served as the liaison between ISO TC 194 Sterilization Standards and IEC SC 62 Medical Electrical standards. Mr. Bills has presented courses for the American Association of Medical Instrumentation (AAMI) and the Advanced Medical Technology Association (AdvaMed), and as guest lecturer at the University of Southern California graduate program in Regulatory Affairs and the University of Washington certificate program in Regulatory Affairs.

Currently he is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management. Working as a consultant, Mr. Bills has assisted major medical device manufacturers improve their risk management processes to comply with regulatory requirements and international standards. He has also assisted with the development and improvement of design, development, manufacturing and service processes and preparation of pre-market submissions for manufacturers in the medical device industry. Mr. Bills has also provided expert services to legal counsel in the area of risk management and FDA compliance.

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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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