Process Validation Principles And Protocols For Medical Devices From Globalcompliancepanel
Description:
Description:One of the hallmarks of a scientific process is that it should be consistently and repeatedly demonstrable and predictable.Process lies at the heart of a high-specialty product such as a medical device, because this is what helps the device meet expected criteria. This is why a medical device has to meet very stringent and robust process validation and verification requirements when being manufactured.
That process validation is a core part of both automated and manual devices is an indication of the importance process validation and verification has to medical devices. It has to be carried out in such a way that it consistently meets set domestic and international standards.
This webinar will familiarize participants with the ins and outs of process validation and verification. Participants of this session will gain an in-depth understanding of the topic. These are the areas this webinar will address:
oWhat is Validation?
oWhen should it be used?
oHow does it differ from verification?
oValidation vs. Verification: Which One?
oProtocol preparation
oDifferent types of validation
oIQ, OQ, and PQ
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When:November 15, 10:00 AM PDT | 01:00 PM EDT
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By whom:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. In this position, Jeff holds the critical portfolio of being responsible for oversight of corporate compliance with domestic and international regulations and preparation of submissions, and is the primary liaison point with regulatory agencies and notified bodies.
Performing such challenging tasks day in and day out has given Jeff deep knowledge of regulatory affairs, which he has imparted in the dozens of webinars he has presented in many areas dealing with regulatory compliance. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Delivering on challenges has thus never been new to Jeff. Jeff received his Regulatory Affairs Certification in 1996.
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For whom:
oValidation Specialists/Managers
oProcess Engineers
oManufacturing Engineers
oQuality Engineers
oProduct/Process Development personnel
oResearch and Development personnel
oQuality/Regulatory Personnel
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Duration: 60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407
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