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Use of Risk Management during Process and Design Validation  

Course "Efficient Use of Risk Management during Process and Design Validation" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

 

Date & Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 90 Minutes

Instructor: Edwin L Bills

Location: Online

Price : $245.00

Edwin L Bills Principal Consultant, Bilanx Consulting LLC

(for one participant)

Overview: In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. The international standard on medical device Risk Management impacts this phase through a requirement for verification of risk control effectiveness. In order to accomplish Design Validation, Process Validation must be partially completed. In order to complete Design Validation, regulators expect Risk Management to be completed. This presentation will discuss this critical interface between these three elements and give medical device manufacturers practical advice on implementation of a process that meets the requirements of all three areas.

Areas Covered in the Session:

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Instructor Profile:

Tuesday, June 19, 2012

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Regulators expectations for Design Validation Product requirements for Design Validation Providing validated production for Design Validation How does risk management guide Process Validation? What aspects of risk control must be included in Design Validation? Developing a validation plan and protocol that meets regulatory requirements

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During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. 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 this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management. ...more

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Project Managers

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Design Engineers Quality Engineers Process Engineers

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Design Validation Team Process Validation Team

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Use of Risk Management during Process and Design Validation