RAPS Approved Webinar on
Process Validation Principles and Protocols for Medical Devices Date: Thursday, November 15, 2012
Time: 10:00 AM PDT | 01:00 PM EDT
Course "Process Validation Principles and Protocols for Medical Devices" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.
Duration: 60 Minutes Instructor: Jeff Kasoff Location: Online Price : $245.00 (for one participant)
Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, ...more
Overview: The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit. Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. These requirements are applicable to both automated and manual processes. This webinar explains the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place.
Areas Covered in the Session: l l l l l l l
What is Validation? When should it be used? How does it differ from verification? Validation vs. Verification: Which One? Protocol preparation Different types of validation IQ, OQ, and PQ
Who Will Benefit: l
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Process Engineers Manufacturing Engineers Quality Engineers
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Product/Process Development personnel
Research and Development personnel Quality/Regulatory
Click here to register for this webinar
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The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize thei...