Live Webinar
on
Use of Risk Management during Process and Design Validation
Date & Time: Tuesday, April 3, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Edwin L Bills
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
Edwin L Bills Principal Consultant, Bilanx Consulting LLC
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: l l l l l
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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
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. ...more
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Click here to register for this webinar Who Will Benefit: l l
Project Managers Design Engineers
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Quality Engineers Process Engineers Design Validation Team
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Process Validation Team
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