Live Webinar on
Process Validation Principles and Protocols for Medical Devices
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
Date & Time: Instructor Profile:
Thursday, May 31, 2012 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes Instructor: Jeff Kasoff Director of Regulatory
Affairs, Life-Tech, Inc
Location: Online Price : $245.00 (for one participant)
Jeff Kasoff, RAC, is the Director of
Quality at Byrne Medical, a leading
Overview: manufacturer of endoscopy and
The benefit of a consistent process is that the yield meets expected colonoscopy devices, where he
criteria. Firms that are able to implement such processes minimize oversees the operation of the quality
their process rejections and therefore maximize profit. system. In this position, Jeff is
responsible for oversight of the
document control system, including
Domestic and international regulations actually assist in this
maintenance of regulatory
endeavor, by setting forth the requirements to assure a process is documentation. Prior to this, Jeff
consistent, and that it yields output that is both safe and effective. spent 13 years at Life-Tech, Inc. as
These requirements are applicable to both automated and manual the Director of Regulatory Affairs,
processes. This webinar explains the regulatory requirements for where he was responsible for
process validation, and also includes definitions and application of compliance of the corporate quality
applicable terminology, and hints and recommendation for the more system. Jeff received his regulatory
affairs certification in 1996. ...more
common types of process validation. Also covered will be the
validation technique used for processes that are already in place.
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Areas Covered in the Session:
Your Necessity is our Priority
l What is Validation?
l When should it be used?
l How does it differ from verification?
l Validation vs. Verification: Which One?
l Protocol preparation
l Different types of validation
l IQ, OQ, and PQ
Click here to register for this webinar
Who Will Benefit:
l Validation Specialists/Managers
l Process Engineers
l Manufacturing Engineers
l Quality Engineers
l Product/Process Development personnel
l Research and Development personnel
l Quality/Regulatory Personnel
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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